Trial Condition(s):
Hypertension, Essential
Study of Nifedipine GITS and Candesartan Combination compared to monotherapy in patients with essential hypertension (DISTINCT)
Trial Purpose
The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active ingredient). The drugs – nifedipine GITS and candesartan - which are being investigated are currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimens will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.
Inclusion Criteria
- Male and female subjects 18 years or older. Female subjects must be either post-menopausal for one year, surgically sterile, or using an effective contraceptive method. Hormonal contraceptive use is disallowed. - Subjects must have mild to moderate essential hypertension (Grade 1 and 2 WHO classifications) as measured by calibrated standard sphygmomanometer. (MSDBP of ≥90 mmHg and < 110 mmHg at Visit 1 (placebo run-in), and MSDBP of ≥95 mmHg and < 110 mmHg at visit 2 (randomization) - Subjects must have an absolute difference in their MSDBP of less than 10 mmHg between Visit 1 (placebo run- in) and Visit 2 (randomization).
Exclusion Criteria
- Severe hypertension (Grade 3 WHO classification; MSDBP ≥110 mmHg and/or MSSBP ≥ 180 mmHg) - Inability to washout of antihypertensive drugs (even if prescribed for another indication) safely for a period of 14 weeks. - History of hypertensive retinopathy – known Keith-Wagener Grade III or IV - History of hypertensive encephalopathy - Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the previous 12 months - History of intracerebral hemorrhage or subarachnoid hemorrhage - Evidence of secondary hypertension such as coarchation of the aorta, pheochromocytoms, hypersaldosteronism, etc. - Type I diabetes mellitus (DM) or poorly controlled DM Type II as evidenced by a glycosylated hemoglobin [HbA1C] of greater than 9% on visit 1. - Allergies or known intolerance to one of the investigational drugs/drug class or to one of their ingredients - Any history of heart failure, New York Heart Association (NYHA) classification III or IV - Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 1. - Clinically significant cardiac valvular disease - History of malignancy in the last 5 years, excluding basal or skin cancer - Uncorrected hypokalemia or hyperkalemia: potassium outside 3.0-5.0 mmol/L - Surgical or medical conditions that might alter the metabolism, excretion or distribution or absorption of any drug a) Gastrointestinal disease or surgery resulting in the potential for malabsorption b) Severe gastrointestinal tract narrowing; kock pouch (ileostomy after proctocolectomy) c) Cholestasis or biliary obstruction or history of pancreatic injury or clinical significant increase of lipase, amylase, or bilirubin. d) Liver disease or AST/ALT levels >3 x ULN e) Renal insufficiency, defined as eGFR of < 50 mL/min (computed using the Cockroft-Gault formula), or on hemodialysis - Investigation trial participation with receipt of investigational study drug within the last month - Previous assignment to treatment in this study - Female subjects who are pregnant or lactating. - Subjects who have night employment (night shift). - Subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study. - Thought by the investigator for any reason to be unsuitable for participation in a clinical study - Systemic use of known cytochrome P450-3A4 inhibitors (e.g cimetidine, anti-human immunodeficiency virus [HIV] protease inhibitors e.g. ritonavir, azole anti-mycotics eg. ketoconazole,) or inducers (e.g rifampicin, anti-epileptic drugs eg. phenytoin, carbamazepine and phenobarbitone) or some P450-3A4 substrates (e.g quinidine, digoxin, tacrolimus) - Present severe rhythm or conduction disorder: - Atrial fibrillation - Second or third degree heart block without a pacemaker. - Baseline QTc >450 msec - History of non-compliance, alcoholism or drug abuse that in the opinion of the investigator will compromise successful completion of the study. - If differences greater than 20 mmHg for SBP and 10 mmHg for DBP are present on 3 consecutive BP readings, the subject should be excluded from the study.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Newmarket, Canada, L3Y 5G8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Addlestone, United Kingdom, KT15 2BH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Chesterfield, United Kingdom, S40 4AA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Trowbridge, United Kingdom, BA14 8QA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bath, United Kingdom, BA2 4JT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Chippenham, United Kingdom, SN15 2SB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Leamington Spa, United Kingdom, CV32 4RA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Fowey, United Kingdom, PL23 1DT | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Penzance, United Kingdom, TR18 4JH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Penzance, United Kingdom, TR19 7HX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Blackpool, United Kingdom, FY3 7EN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Mt. Pleasant, United States, 29464 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Dallas, United States, 75230 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Jacksonville, United States, 32216 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cincinnati, United States, 45224 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Mobile, United States, 36617 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Atlanta, United States, 30338 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Salisbury, United States, 28144 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Charlotte, United States, 28209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sassari, Italy, 07100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Chieti, Italy, 66013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Milano, Italy, 20132 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Granada, Spain, 18012 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Petrer, Spain, 03610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Peralada, Spain, 17491 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Montreal, Canada, H4N 2W2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. John's, Canada, A1A 3R5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. John's, Canada, A1E 2E2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sarnia, Canada, N7T 4X3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Corunna, Canada, N0N 1G0 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Langley, Canada, V3A 4H9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Downsview, Canada, M3J 1N2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 150-713 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Goyang-si, South Korea, 411-706 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 120-752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 135-720 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Busan, South Korea, 602-793 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Uijeongbu, South Korea, 480-130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 156-707 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 156-755 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 158 710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Goyang-si, South Korea, 410-773 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Wonju-si, South Korea, 220-701 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 152-703 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 150-950 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 110-744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Daejeon, South Korea, 301-723 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Goyang-si, South Korea, 412-270 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kaunas, Lithuania, LT-50009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Vilnius, Lithuania, LT-08661 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kaunas, Lithuania, LT-49387 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Alytus, Lithuania, LT-62381 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Valencia, Spain, 46006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hostalets de Balenyà, Spain, 08550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Stellenbosch, South Africa, 7505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Roodepoort, South Africa, 1724 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Port Elizabeth, South Africa, 6014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Johannesburg, South Africa | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Witbank, South Africa, 1035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pisa, Italy, 56124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pavia, Italy, 27100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Trieste, Italy, 34149 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Perugia, Italy, 06129 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Mercato San Severino, Italy, 84085 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Durban, South Africa, 4037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site São Paulo, Brazil, 04025-011 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sao Paulo, Brazil, 01244-030 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Fortaleza, Brazil, 60120-021 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Goiania, Brazil, 74605-050 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Rio de Janeiro, Brazil, 22271-100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Campinas, Brazil, 13010-001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Campinas, Brazil, 13060904 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Brasília, Brazil, 71265 009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bahía Blanca, Argentina, 8000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Zárate, Argentina, B2800DGH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Santa Fe, Argentina, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1425AWC | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1425DES | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1430AAQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Córdoba, Argentina, X5002AOQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Rosario, Argentina, 2000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Córdoba, Argentina, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, C1440AAD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Quilmes, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kiev, Ukraine, 01 151 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kiev, Ukraine, 03680 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kiev, Ukraine, 01151 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Zhytomyr, Ukraine, 10002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kharkiv, Ukraine, 61176 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 197022 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 117997 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 199106 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Smolensk, Russia, 214019 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 197341 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 125284 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 115432 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 195112 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St Petersburg, Russia, 198013 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 196247 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 119048 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Moscow, Russia, 119415 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 198205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St. Petersburg, Russia, 195271 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Deurne, Belgium, 2100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site HAM, Belgium, 3545 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Wetteren, Belgium, 9230 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site De Pinte, Belgium, 9840 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Greenville, United States, 29615 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Deerfield Beach, United States, 33321 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Valparaiso, United States, 46383 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Coral Gables, United States, 33114-4192 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Raleigh, United States, 27609 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kiev, Ukraine, 02660 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Vinnitsa, Ukraine, 2108 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Benidorm, Spain, 03503 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Goyang-Si, South Korea, 410-719 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Anyang-si, South Korea, 431-070 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Seoul, South Korea, 133-792 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Chungchungbuk-do, South Korea, 361-711 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Oviedo, Spain, 33013 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Huelva, Spain, 21003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bath, United Kingdom, BA11 2FH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site St Austell, United Kingdom, PL26 7RL | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kiev, Ukraine, 02 091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Dnipropetrovsk, Ukraine, 49060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Zaporizhzhya, Ukraine, 69118 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Somerset West, South Africa, 7130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Petoria, South Africa | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Los Angeles, United States, 90057 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Salt Lake City, United States, 84121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site West Palm Beach, United States, 33409 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Philadelphia, United States, 19142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Deerfield Beach, United States, 33441 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Harrisburg, United States, 28075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Salt Lake City, United States, 84109 | Status Completed | Contact Us: E-mail: clinical-trials-[email protected] Phone: Not Available | |
Locations Investigative Site San Antonio, United States, 78205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kenosha, United States, 53142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, Canada, N5W 6A2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Toronto, Canada, M9V 4B4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Etobicoke, Canada, M8V 3X8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Toronto, Canada, M9W 4L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Brampton, Canada, L6T 0G1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Strathroy, Canada, N7G 1Y7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site London, Canada, N5Y 5K7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Glasgow, United Kingdom, G20 0XA | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Glasgow, United Kingdom, G20 7LR | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bath, United Kingdom, BA3 2UH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Coventry, United Kingdom, CV6 4DD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Corrientes, Argentina, 3400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Buenos Aires, Argentina, 1405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ft. Lauderdale, United States, 33309 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bath, United Kingdom, BA2 4BY | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Westbury, United Kingdom, BA13 3JD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of Nifedipine GITS and Candesartan in Combination Compared to Monotherapy in Adult Patients with Essential Hypertension
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
16
Primary Outcome
- The primary efficacy variable is the change from baseline in mean seated diastolic blood pressure (MSDBP) at Week 8Timeframe: Baseline taken at Visit 1; primary outcome variable assesed at 8 weeks
Secondary Outcome
- Change in mean seated systolic blood pressure (MSSBP) at Week 8Timeframe: 8 weeks
- Control rate at Week 8Timeframe: 8 weeks
- Response rate at Week 8Timeframe: 8 weeks
- Peripheral EdemaTimeframe: 8 weeks
- Time to achieve first BP controlTimeframe: 8 weeks
Additional Information
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