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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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) (Drug); Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) (Drug); Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) (Drug); Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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.

Clinical Details

Official title: Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects With Moderate to Severe Essential Hypertension

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28

Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28

Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)

Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)

Secondary outcome:

Number of Subjects With Clinically Relevant Changes in Laboratory Parameters

Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52

Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52

Blood Pressure Control Rate at Weeks 28 and 52

Blood Pressure Response Rate at Weeks 28 and 52

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 Mean sitting systolic blood pressure (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

Locations and Contacts

Deurne 2100, Belgium

HAM 3545, Belgium

Berlin 12627, Germany

Dresden, Germany

Gdynia 81-384, Poland

Katowice 40-040, Poland

Warszawa 01-192, Poland

Wroclaw 50-088, Poland

Cardiff CF14 5GJ, United Kingdom

Chorley PR7 7NA, United Kingdom

Glasgow G20 OSP, United Kingdom

Liverpool L22 0LG, United Kingdom

Manchester M15 6SX, United Kingdom

Foley, Alabama 36535, United States

Reading, Berkshire RG2 0TG, United Kingdom

Burnaby, British Columbia V5G 1T4, Canada

Langley, British Columbia V3A 4H9, Canada

Vancouver, British Columbia V5Z 1K3, Canada

Carmichael, California 95608, United States

Los Angeles, California 90057, United States

Spring Valley, California 91978, United States

Milford, Connecticut 06460, United States

Chesterfield, Derbyshire S40 4AA, United Kingdom

Coral Gables, Florida 33114-4192, United States

Hallandale Beach, Florida 33009, United States

Hollywood, Florida 33083, United States

Jacksonville, Florida 32216, United States

Jupiter, Florida 33458, United States

Tampa, Florida 33606, United States

Atlanta, Georgia 30338, United States

Frankfurt, Hessen 60596, Germany

Valparaiso, Indiana 46383, United States

Newton, Kansas 67114, United States

Wichita, Kansas 67205, United States

Lexington, Kentucky 40504, United States

Blackpool, Lancashire FY3 7EN, United Kingdom

New Orleans, Louisiana 70119, United States

Auburn, Maine 04240, United States

Elkridge, Maryland 21075, United States

Brockton, Massachusetts 02301, United States

St. Louis, Missouri 63141, United States

Bochum, Nordrhein-Westfalen 44787, Germany

Shelby, North Carolina 28150, United States

Cincinnati, Ohio 45224, United States

Cincinnati, Ohio 45245, United States

Cincinnati, Ohio 45246, United States

Columbus, Ohio 43213, United States

Brampton, Ontario L6T 0G1, Canada

Burlington, Ontario L7M 4Y1, Canada

Etobicoke, Ontario M8V 3X8, Canada

London, Ontario N5W 6A2, Canada

Newmarket, Ontario L3Y 5G8, Canada

Sarnia, Ontario N7T 4X3, Canada

Stayner, Ontario L0M 1S0, Canada

Toronto, Ontario M9V 4B4, Canada

Toronto, Ontario M4S 1Y2, Canada

Woodstock, Ontario N4S 4G3, Canada

Moorsel, Oost-Vlaanderen 9310, Belgium

Wetteren, Oost-Vlaanderen 9230, Belgium

Pointe-Claire, Quebec H9R 3J1, Canada

Ste-Foy, Quebec G1W 1S2, Canada

Görlitz, Sachsen 02826, Germany

Leipzig, Sachsen 04103, Germany

Magdeburg, Sachsen-Anhalt 39104, Germany

Bath, Somerset BA3 2UH, United Kingdom

Greenville, South Carolina 29615, United States

Mt. Pleasant, South Carolina 29464, United States

Rapid City, South Dakota 57702, United States

Bury St Edmonds, Suffolk IP30 9QU, United Kingdom

Nashville, Tennessee 37203, United States

New Tazewell, Tennessee 37825, United States

Beaumont, Texas 77701, United States

Bryan, Texas 77802, United States

Carrollton, Texas 75010, United States

Dallas, Texas 75230, United States

San Antonio, Texas 78229, United States

Salt Lake City, Utah 84109, United States

Salt Lake City, Utah 84121, United States

Steenokkerzeel, Vlaams Brabant 1820, Belgium

Coventry, Warwickshire CV6 4DD, United Kingdom

Birmingham, West Midlands B15 2SQ, United Kingdom

Kenosha, Wisconsin 53142, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Starting date: February 2013
Last updated: July 21, 2015

Page last updated: August 23, 2015

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