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
NCT ID: NCT01788358
Last Updated: 2017-10-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
508 participants
INTERVENTIONAL
2013-02-14
2014-05-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram \[mg\] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily
Interventions
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Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily
Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Foley, Alabama, United States
Carmichael, California, United States
Los Angeles, California, United States
Spring Valley, California, United States
Milford, Connecticut, United States
Coral Gables, Florida, United States
Hallandale, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Valparaiso, Indiana, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Auburn, Maine, United States
Elkridge, Maryland, United States
Brockton, Massachusetts, United States
St Louis, Missouri, United States
Shelby, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Greenville, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
New Tazewell, Tennessee, United States
Beaumont, Texas, United States
Bryan, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Kenosha, Wisconsin, United States
Moorsel, Oost-Vlaanderen, Belgium
Wetteren, Oost-Vlaanderen, Belgium
Steenokkerzeel, Vlaams Brabant, Belgium
Deurne, , Belgium
Ham, , Belgium
Burnaby, British Columbia, Canada
Langley, British Columbia, Canada
Vancouver, British Columbia, Canada
Brampton, Ontario, Canada
Burlington, Ontario, Canada
Etobicoke, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Sarnia, Ontario, Canada
Stayner, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Woodstock, Ontario, Canada
Pointe-Claire, Quebec, Canada
Ste-Foy, Quebec, Canada
Frankfurt am Main, Hesse, Germany
Bochum, North Rhine-Westphalia, Germany
Görlitz, Saxony, Germany
Leipzig, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, , Germany
Dresden, , Germany
Gdynia, , Poland
Katowice, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Reading, Berkshire, United Kingdom
Chesterfield, Derbyshire, United Kingdom
Blackpool, Lancashire, United Kingdom
Bath, Somerset, United Kingdom
Bury Saint Edmonds, Suffolk, United Kingdom
Coventry, Warwickshire, United Kingdom
Birmingham, West Midlands, United Kingdom
Cardiff, , United Kingdom
Chorley, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
Manchester, , United Kingdom
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2012-004515-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14801
Identifier Type: -
Identifier Source: org_study_id