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:

NCT01303783

EudraCT Number:

2009-017077-37

Study Completed

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
1381
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Newmarket, Canada, L3Y 5G8

Status
Completed
 
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Addlestone, United Kingdom, KT15 2BH

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Completed
 
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Chesterfield, United Kingdom, S40 4AA

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Completed
 
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Trowbridge, United Kingdom, BA14 8QA

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Completed
 
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Bath, United Kingdom, BA2 4JT

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Completed
 
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Chippenham, United Kingdom, SN15 2SB

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Completed
 
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Leamington Spa, United Kingdom, CV32 4RA

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Completed
 
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Fowey, United Kingdom, PL23 1DT

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Terminated
 
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Penzance, United Kingdom, TR18 4JH

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Completed
 
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Penzance, United Kingdom, TR19 7HX

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Completed
 
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Blackpool, United Kingdom, FY3 7EN

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Completed
 
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Mt. Pleasant, United States, 29464

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Completed
 
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Dallas, United States, 75230

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Completed
 
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Jacksonville, United States, 32216

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Cincinnati, United States, 45224

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Completed
 
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Mobile, United States, 36617

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Atlanta, United States, 30338

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Salisbury, United States, 28144

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Completed
 
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Charlotte, United States, 28209

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Completed
 
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Pavia, Italy, 27100

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Completed
 
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Sassari, Italy, 07100

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Completed
 
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Chieti, Italy, 66013

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Completed
 
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Milano, Italy, 20132

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Terminated
 
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Granada, Spain, 18012

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Completed
 
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Petrer, Spain, 03610

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Completed
 
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Peralada, Spain, 17491

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Completed
 
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Montreal, Canada, H4N 2W2

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Completed
 
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St. John's, Canada, A1A 3R5

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Completed
 
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St. John's, Canada, A1E 2E2

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Completed
 
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Sarnia, Canada, N7T 4X3

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Completed
 
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Corunna, Canada, N0N 1G0

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Completed
 
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Langley, Canada, V3A 4H9

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Completed
 
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Downsview, Canada, M3J 1N2

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Completed
 
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Seoul, South Korea, 150-713

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Completed
 
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Goyang-si, South Korea, 411-706

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Completed
 
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Seoul, South Korea, 120-752

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Completed
 
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Seoul, South Korea, 135-720

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Completed
 
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Busan, South Korea, 602-793

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Completed
 
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Uijeongbu, South Korea, 480-130

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Completed
 
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Seoul, South Korea, 156-707

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Terminated
 
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Seoul, South Korea, 156-755

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Completed
 
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Seoul, South Korea, 158 710

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Completed
 
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Goyang-si, South Korea, 410-773

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Completed
 
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Wonju-si, South Korea, 220-701

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Completed
 
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Seoul, South Korea, 152-703

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Completed
 
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Seoul, South Korea, 150-950

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Seoul, South Korea, 110-744

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Completed
 
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Daejeon, South Korea, 301-723

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Completed
 
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Goyang-si, South Korea, 412-270

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Kaunas, Lithuania, LT-50009

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Completed
 
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Vilnius, Lithuania, LT-08661

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Completed
 
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Kaunas, Lithuania, LT-49387

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Completed
 
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Alytus, Lithuania, LT-62381

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Completed
 
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Valencia, Spain, 46006

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Completed
 
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Hostalets de Balenyà, Spain, 08550

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Completed
 
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Stellenbosch, South Africa, 7505

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Completed
 
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Roodepoort, South Africa, 1724

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Completed
 
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Port Elizabeth, South Africa, 6014

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Completed
 
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Johannesburg, South Africa

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Completed
 
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Witbank, South Africa, 1035

Status
Completed
 
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Pisa, Italy, 56124

Status
Completed
 
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Investigative Site

Pavia, Italy, 27100

Status
Terminated
 
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Trieste, Italy, 34149

Status
Terminated
 
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Bologna, Italy, 40138

Status
Completed
 
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Perugia, Italy, 06129

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Completed
 
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Mercato San Severino, Italy, 84085

Status
Completed
 
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Durban, South Africa, 4037

Status
Completed
 
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Investigative Site

São Paulo, Brazil, 04025-011

Status
Terminated
 
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Investigative Site

Sao Paulo, Brazil, 01244-030

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Terminated
 
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Fortaleza, Brazil, 60120-021

Status
Terminated
 
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Investigative Site

Goiania, Brazil, 74605-050

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Terminated
 
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Investigative Site

Rio de Janeiro, Brazil, 22271-100

Status
Terminated
 
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Campinas, Brazil, 13010-001

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Terminated
 
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Campinas, Brazil, 13060904

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Terminated
 
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Brasília, Brazil, 71265 009

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Terminated
 
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Investigative Site

Bahía Blanca, Argentina, 8000

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Completed
 
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Zárate, Argentina, B2800DGH

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Completed
 
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Santa Fe, Argentina, 3000

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Completed
 
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Buenos Aires, Argentina, C1425AWC

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Completed
 
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Buenos Aires, Argentina, C1280AEB

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Completed
 
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Buenos Aires, Argentina, C1425DES

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Completed
 
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Buenos Aires, Argentina, C1430AAQ

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Completed
 
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Córdoba, Argentina, X5002AOQ

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Completed
 
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Rosario, Argentina, 2000

Status
Completed
 
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Investigative Site

Córdoba, Argentina, 5000

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Completed
 
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Buenos Aires, Argentina, C1440AAD

Status
Completed
 
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Quilmes, Argentina

Status
Completed
 
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Kiev, Ukraine, 01 151

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Completed
 
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Investigative Site

Kiev, Ukraine, 03680

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Completed
 
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Investigative Site

Kiev, Ukraine, 01151

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Completed
 
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Investigative Site

Zhytomyr, Ukraine, 10002

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Completed
 
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Investigative Site

Kharkiv, Ukraine, 61176

Status
Completed
 
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Investigative Site

St. Petersburg, Russia, 197022

Status
Terminated
 
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Investigative Site

Moscow, Russia, 117997

Status
Terminated
 
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Investigative Site

St. Petersburg, Russia, 199106

Status
Terminated
 
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Investigative Site

Smolensk, Russia, 214019

Status
Terminated
 
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Investigative Site

St. Petersburg, Russia, 197341

Status
Terminated
 
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Investigative Site

Moscow, Russia, 125284

Status
Terminated
 
Locations

Investigative Site

Moscow, Russia, 115432

Status
Terminated
 
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Investigative Site

St. Petersburg, Russia, 195112

Status
Terminated
 
Locations

Investigative Site

St Petersburg, Russia, 198013

Status
Terminated
 
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Investigative Site

St. Petersburg, Russia, 196247

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Terminated
 
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Investigative Site

Moscow, Russia, 119048

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Terminated
 
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Investigative Site

Moscow, Russia, 119415

Status
Completed
 
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Investigative Site

St. Petersburg, Russia, 198205

Status
Completed
 
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Investigative Site

St. Petersburg, Russia, 195271

Status
Terminated
 
Locations

Investigative Site

Deurne, Belgium, 2100

Status
Completed
 
Locations

Investigative Site

HAM, Belgium, 3545

Status
Completed
 
Locations

Investigative Site

Wetteren, Belgium, 9230

Status
Completed
 
Locations

Investigative Site

De Pinte, Belgium, 9840

Status
Completed
 
Locations

Investigative Site

Greenville, United States, 29615

Status
Completed
 
Locations

Investigative Site

Deerfield Beach, United States, 33321

Status
Completed
 
Locations

Investigative Site

Valparaiso, United States, 46383

Status
Completed
 
Locations

Investigative Site

Coral Gables, United States, 33114-4192

Status
Completed
 
Locations

Investigative Site

Raleigh, United States, 27609

Status
Completed
 
Locations

Investigative Site

Kiev, Ukraine, 02660

Status
Completed
 
Locations

Investigative Site

Vinnitsa, Ukraine, 2108

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Santiago de Compostela, Spain, 15706

Status
Terminated
 
Locations

Investigative Site

Benidorm, Spain, 03503

Status
Completed
 
Locations

Investigative Site

Goyang-Si, South Korea, 410-719

Status
Terminated
 
Locations

Investigative Site

Anyang-si, South Korea, 431-070

Status
Terminated
 
Locations

Investigative Site

Seoul, South Korea, 133-792

Status
Completed
 
Locations

Investigative Site

Chungchungbuk-do, South Korea, 361-711

Status
Completed
 
Locations

Investigative Site

Oviedo, Spain, 33013

Status
Terminated
 
Locations

Investigative Site

Huelva, Spain, 21003

Status
Completed
 
Locations

Investigative Site

Bath, United Kingdom, BA11 2FH

Status
Completed
 
Locations

Investigative Site

St Austell, United Kingdom, PL26 7RL

Status
Completed
 
Locations

Investigative Site

Kiev, Ukraine, 02 091

Status
Completed
 
Locations

Investigative Site

Dnipropetrovsk, Ukraine, 49060

Status
Completed
 
Locations

Investigative Site

Zaporizhzhya, Ukraine, 69118

Status
Completed
 
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Investigative Site

Somerset West, South Africa, 7130

Status
Completed
 
Locations

Investigative Site

Petoria, South Africa

Status
Terminated
 
Locations

Investigative Site

Los Angeles, United States, 90057

Status
Completed
 
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Investigative Site

Salt Lake City, United States, 84121

Status
Completed
 
Locations

Investigative Site

West Palm Beach, United States, 33409

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19142

Status
Completed
 
Locations

Investigative Site

Deerfield Beach, United States, 33441

Status
Completed
 
Locations

Investigative Site

Harrisburg, United States, 28075

Status
Completed
 
Locations

Investigative Site

Salt Lake City, United States, 84109

Status
Completed
 
Locations

Investigative Site

San Antonio, United States, 78205

Status
Completed
 
Locations

Investigative Site

Kenosha, United States, 53142

Status
Completed
 
Locations

Investigative Site

London, Canada, N5W 6A2

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M9V 4B4

Status
Completed
 
Locations

Investigative Site

Etobicoke, Canada, M8V 3X8

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M9W 4L6

Status
Completed
 
Locations

Investigative Site

Brampton, Canada, L6T 0G1

Status
Completed
 
Locations

Investigative Site

Strathroy, Canada, N7G 1Y7

Status
Completed
 
Locations

Investigative Site

London, Canada, N5Y 5K7

Status
Completed
 
Locations

Investigative Site

Glasgow, United Kingdom, G20 0XA

Status
Terminated
 
Locations

Investigative Site

Glasgow, United Kingdom, G20 7LR

Status
Terminated
 
Locations

Investigative Site

Bath, United Kingdom, BA3 2UH

Status
Completed
 
Locations

Investigative Site

Coventry, United Kingdom, CV6 4DD

Status
Completed
 
Locations

Investigative Site

Corrientes, Argentina, 3400

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, 1405

Status
Completed
 
Locations

Investigative Site

Ft. Lauderdale, United States, 33309

Status
Completed
 
Locations

Investigative Site

Bath, United Kingdom, BA2 4BY

Status
Terminated
 
Locations

Investigative Site

Westbury, United Kingdom, BA13 3JD

Status
Completed
 

Trial Design