Trial Condition(s):

Hypertension

Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects with Moderate to Severe Essential Hypertension

Bayer Identifier:

14801

ClinicalTrials.gov Identifier:

NCT01788358

EudraCT Number:

2012-004515-32

Study Completed

Trial Purpose

This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.
Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total).
Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose.

Inclusion Criteria
- Subjects must have moderate to severe essential hypertension (Grade 2 or  Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of >/= 160 mmHg and < 200 mmHg, as measured by a calibrated electronic BP measuring device. For other subjects who are treated with antihypertensive medication before, they should have MSSBP >/= 160 mmHg and <200 mmHg after wash out.
 - Women of childbearing potential and men must agree to use adequate contraception  other than hormonal contraceptives when sexually active
Exclusion Criteria
- Mean seated systolic blood pressure >/= 200 mmHg and/or mean seated diastolic blood pressure >/= 120 mm/Hg
 - Mean seated diastolic blood pressure < 60 mm/Hg
 - Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0 
 - Any history of hypertensive emergency
 - Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
 - Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the previous 12 months
 - History of intracerebral hemorrhage or subarachnoid hemorrhage 
 - History of hypertensive retinopathy – known Keith-Wagener Grade III or IV
 - 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 0 
 - Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0.
 - Hyperkalemia: potassium above the upper limit of normal in the laboratory range

Trial Summary

Enrollment Goal
508
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
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

Greenville, United States, 29615

Status
Completed
 
Locations

Investigative Site

Coral Gables, United States, 33114-4192

Status
Terminated
 
Locations

Investigative Site

Nashville, United States, 37203

Status
Completed
 
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Investigative Site

Salt Lake City, United States, 84121

Status
Completed
 
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Investigative Site

Cincinnati, United States, 45224

Status
Completed
 
Locations

Investigative Site

Salt Lake City, United States, 84109

Status
Completed
 
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Investigative Site

Los Angeles, United States, 90057

Status
Completed
 
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Investigative Site

Atlanta, United States, 30338

Status
Completed
 
Locations

Investigative Site

Rapid City, United States, 57702

Status
Completed
 
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Investigative Site

Valparaiso, United States, 46383

Status
Completed
 
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Investigative Site

Newton, United States, 67114

Status
Completed
 
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Investigative Site

Wichita, United States, 67205

Status
Completed
 
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Investigative Site

New Orleans, United States, 70119

Status
Completed
 
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Investigative Site

Auburn, United States, 04240

Status
Completed
 
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Kenosha, United States, 53142

Status
Completed
 
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Dallas, United States, 75230

Status
Completed
 
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Hollywood, United States, 33083

Status
Completed
 
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Hallandale Beach, United States, 33009

Status
Completed
 
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Shelby, United States, 28150

Status
Completed
 
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Tampa, United States, 33606

Status
Completed
 
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Cincinnati, United States, 45245

Status
Completed
 
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Cincinnati, United States, 45246

Status
Completed
 
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Jupiter, United States, 33458

Status
Completed
 
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Carrollton, United States, 75010

Status
Completed
 
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New Tazewell, United States, 37825

Status
Completed
 
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Mt. Pleasant, United States, 29464

Status
Completed
 
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Lexington, United States, 40504

Status
Completed
 
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Jacksonville, United States, 32216

Status
Completed
 
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Beaumont, United States, 77701

Status
Completed
 
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Foley, United States, 36535

Status
Completed
 
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Columbus, United States, 43213

Status
Completed
 
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Carmichael, United States, 95608

Status
Completed
 
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Investigative Site

St. Louis, United States, 63141

Status
Terminated
 
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Investigative Site

San Antonio, United States, 78229

Status
Completed
 
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Investigative Site

Elkridge, United States, 21075

Status
Completed
 
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Milford, United States, 06460

Status
Completed
 
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Investigative Site

Brockton, United States, 02301

Status
Completed
 
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Spring Valley, United States, 91978

Status
Completed
 
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Bryan, United States, 77802

Status
Completed
 
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Leipzig, Germany, 04103

Status
Completed
 
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Berlin, Germany, 12627

Status
Completed
 
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Bochum, Germany, 44787

Status
Completed
 
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Dresden, Germany

Status
Completed
 
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Frankfurt, Germany, 60313

Status
Completed
 
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Görlitz, Germany, 02826

Status
Completed
 
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Magdeburg, Germany, 39104

Status
Completed
 
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Coventry, United Kingdom, CV6 4DD

Status
Completed
 
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Investigative Site

Blackpool, United Kingdom, FY3 7EN

Status
Completed
 
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Bath, United Kingdom, BA3 2UH

Status
Completed
 
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Investigative Site

Bury St Edmonds, United Kingdom, IP30 9QU

Status
Completed
 
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Investigative Site

Chesterfield, United Kingdom, S40 4AA

Status
Completed
 
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Investigative Site

Chorley, United Kingdom, PR7 7NA

Status
Completed
 
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Investigative Site

Manchester, United Kingdom, M15 6SX

Status
Completed
 
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Investigative Site

Liverpool, United Kingdom, L22 0LG

Status
Completed
 
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Investigative Site

Cardiff, United Kingdom, CF14 5GJ

Status
Completed
 
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Investigative Site

Birmingham, United Kingdom, B15 2SQ

Status
Completed
 
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Investigative Site

Glasgow, United Kingdom, G20 OSP

Status
Completed
 
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Investigative Site

Reading, United Kingdom, RG2 0TG

Status
Completed
 
Locations

Investigative Site

Newmarket, Canada, L3Y 5G8

Status
Completed
 
Locations

Investigative Site

Burlington, Canada, L7M 4Y1

Status
Completed
 
Locations

Investigative Site

Burnaby, Canada, V5G 1T4

Status
Completed
 
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Investigative Site

Vancouver, Canada, V5Z 1K3

Status
Completed
 
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Investigative Site

Langley, Canada, V3A 4H9

Status
Completed
 
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Investigative Site

Toronto, Canada, M9V 4B4

Status
Completed
 
Locations

Investigative Site

Woodstock, Canada, N4S 4G3

Status
Completed
 
Locations

Investigative Site

Brampton, Canada, L6T 0G1

Status
Completed
 
Locations

Investigative Site

Sarnia, Canada, N7T 4X3

Status
Completed
 
Locations

Investigative Site

London, Canada, N5W 6A2

Status
Completed
 
Locations

Investigative Site

Etobicoke, Canada, M8V 3X8

Status
Completed
 
Locations

Investigative Site

Stayner, Canada, L0M 1S0

Status
Completed
 
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Investigative Site

Toronto, Canada, M4S 1Y2

Status
Completed
 
Locations

Investigative Site

Pointe-Claire, Canada, H9R 3J1

Status
Completed
 
Locations

Investigative Site

Ste-Foy, Canada, G1W 1S2

Status
Terminated
 
Locations

Investigative Site

Katowice, Poland, 40-040

Status
Terminated
 
Locations

Investigative Site

Wroclaw, Poland, 50-088

Status
Terminated
 
Locations

Investigative Site

Gdynia, Poland, 81-384

Status
Terminated
 
Locations

Investigative Site

Warszawa, Poland, 01-192

Status
Terminated
 
Locations

Investigative Site

Deurne, Belgium, 2100

Status
Terminated
 
Locations

Investigative Site

HAM, Belgium, 3545

Status
Terminated
 
Locations

Investigative Site

Wetteren, Belgium, 9230

Status
Terminated
 
Locations

Investigative Site

MOORSEL, Belgium, 9310

Status
Terminated
 
Locations

Investigative Site

STEENOKKERZEEL, Belgium, 1820

Status
Terminated
 

Trial Design