Trial Condition(s):
Hypertension, Essential
Study of Nifedipine GITS and Candesartan Combination compared to monotherapy in patients with essential hypertension (DISTINCT)
Bayer Identifier:
14725
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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Locations Investigative Site Newmarket, Canada, L3Y 5G8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Addlestone, United Kingdom, KT15 2BH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United Kingdom, S40 4AA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trowbridge, United Kingdom, BA14 8QA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bath, United Kingdom, BA2 4JT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chippenham, United Kingdom, SN15 2SB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leamington Spa, United Kingdom, CV32 4RA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fowey, United Kingdom, PL23 1DT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Penzance, United Kingdom, TR18 4JH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Penzance, United Kingdom, TR19 7HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Blackpool, United Kingdom, FY3 7EN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mt. Pleasant, United States, 29464 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32216 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45224 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mobile, United States, 36617 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30338 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salisbury, United States, 28144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charlotte, United States, 28209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sassari, Italy, 07100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chieti, Italy, 66013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Granada, Spain, 18012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petrer, Spain, 03610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Peralada, Spain, 17491 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H4N 2W2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. John's, Canada, A1A 3R5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. John's, Canada, A1E 2E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sarnia, Canada, N7T 4X3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corunna, Canada, N0N 1G0 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Langley, Canada, V3A 4H9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Downsview, Canada, M3J 1N2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 150-713 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goyang-si, South Korea, 411-706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 135-720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Busan, South Korea, 602-793 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uijeongbu, South Korea, 480-130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 156-707 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 156-755 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 158 710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goyang-si, South Korea, 410-773 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wonju-si, South Korea, 220-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Daejeon, South Korea, 301-723 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goyang-si, South Korea, 412-270 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaunas, Lithuania, LT-50009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Valencia, Spain, 46006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hostalets de Balenyà, Spain, 08550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stellenbosch, South Africa, 7505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roodepoort, South Africa, 1724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Port Elizabeth, South Africa, 6014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Witbank, South Africa, 1035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trieste, Italy, 34149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mercato San Severino, Italy, 84085 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 04025-011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 01244-030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fortaleza, Brazil, 60120-021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goiania, Brazil, 74605-050 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Brasília, Brazil, 71265 009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bahía Blanca, Argentina, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zárate, Argentina, B2800DGH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santa Fe, Argentina, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1425AWC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Córdoba, Argentina, X5002AOQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Argentina, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1440AAD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quilmes, Argentina | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 01 151 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 03680 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 01151 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zhytomyr, Ukraine, 10002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kharkiv, Ukraine, 61176 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117997 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 199106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Smolensk, Russia, 214019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197341 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 125284 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 115432 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 195112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Petersburg, Russia, 198013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 196247 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 119048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 119415 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 198205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 195271 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Deurne, Belgium, 2100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HAM, Belgium, 3545 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wetteren, Belgium, 9230 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site De Pinte, Belgium, 9840 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greenville, United States, 29615 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Deerfield Beach, United States, 33321 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valparaiso, United States, 46383 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coral Gables, United States, 33114-4192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Raleigh, United States, 27609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 02660 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vinnitsa, Ukraine, 2108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Benidorm, Spain, 03503 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goyang-Si, South Korea, 410-719 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Anyang-si, South Korea, 431-070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 133-792 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chungchungbuk-do, South Korea, 361-711 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Huelva, Spain, 21003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bath, United Kingdom, BA11 2FH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Austell, United Kingdom, PL26 7RL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 02 091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dnipropetrovsk, Ukraine, 49060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zaporizhzhya, Ukraine, 69118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Somerset West, South Africa, 7130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petoria, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salt Lake City, United States, 84121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site West Palm Beach, United States, 33409 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Deerfield Beach, United States, 33441 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Harrisburg, United States, 28075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salt Lake City, United States, 84109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Antonio, United States, 78205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kenosha, United States, 53142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N5W 6A2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M9V 4B4 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Glasgow, United Kingdom, G20 0XA | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Bath, United Kingdom, BA3 2UH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coventry, United Kingdom, CV6 4DD | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corrientes, Argentina, 3400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, 1405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ft. Lauderdale, United States, 33309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bath, United Kingdom, BA2 4BY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Westbury, United Kingdom, BA13 3JD | 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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