check_circleStudy Completed

Hypertension

Bayer Identifier:

14801

ClinicalTrials.gov Identifier:

NCT01788358

EudraCT Number:

2012-004515-32

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
February 2013 - May 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Greenville, 29615, United States
Terminated
Coral Gables, 33114-4192, United States
Completed
Nashville, 37203, United States
Completed
Salt Lake City, 84121, United States
Completed
Cincinnati, 45224, United States
Completed
Salt Lake City, 84109, United States
Completed
Los Angeles, 90057, United States
Completed
Atlanta, 30338, United States
Completed
Rapid City, 57702, United States
Completed
Valparaiso, 46383, United States
Completed
Newton, 67114, United States
Completed
Wichita, 67205, United States
Completed
New Orleans, 70119, United States
Completed
Auburn, 04240, United States
Completed
Kenosha, 53142, United States
Completed
Dallas, 75230, United States
Completed
Hollywood, 33083, United States
Completed
Hallandale Beach, 33009, United States
Completed
Shelby, 28150, United States
Completed
Tampa, 33606, United States
Completed
Cincinnati, 45245, United States
Completed
Cincinnati, 45246, United States
Completed
Jupiter, 33458, United States
Completed
Carrollton, 75010, United States
Completed
New Tazewell, 37825, United States
Completed
Mt. Pleasant, 29464, United States
Completed
Lexington, 40504, United States
Completed
Jacksonville, 32216, United States
Completed
Beaumont, 77701, United States
Completed
Foley, 36535, United States
Completed
Columbus, 43213, United States
Completed
Carmichael, 95608, United States
Terminated
St. Louis, 63141, United States
Completed
San Antonio, 78229, United States
Completed
Elkridge, 21075, United States
Completed
Milford, 06460, United States
Completed
Brockton, 02301, United States
Completed
Spring Valley, 91978, United States
Completed
Bryan, 77802, United States
Completed
Leipzig, 04103, Germany
Completed
Berlin, 12627, Germany
Completed
Bochum, 44787, Germany
Completed
Dresden, Germany
Completed
Frankfurt, 60313, Germany
Completed
Görlitz, 02826, Germany
Completed
Magdeburg, 39104, Germany
Completed
Coventry, CV6 4DD, United Kingdom
Completed
Blackpool, FY3 7EN, United Kingdom
Completed
Bath, BA3 2UH, United Kingdom
Completed
Bury St Edmonds, IP30 9QU, United Kingdom
Completed
Chesterfield, S40 4AA, United Kingdom
Completed
Chorley, PR7 7NA, United Kingdom
Completed
Manchester, M15 6SX, United Kingdom
Completed
Liverpool, L22 0LG, United Kingdom
Completed
Cardiff, CF14 5GJ, United Kingdom
Completed
Birmingham, B15 2SQ, United Kingdom
Completed
Glasgow, G20 OSP, United Kingdom
Completed
Reading, RG2 0TG, United Kingdom
Completed
Newmarket, L3Y 5G8, Canada
Completed
Burlington, L7M 4Y1, Canada
Completed
Burnaby, V5G 1T4, Canada
Completed
Vancouver, V5Z 1K3, Canada
Completed
Langley, V3A 4H9, Canada
Completed
Toronto, M9V 4B4, Canada
Completed
Woodstock, N4S 4G3, Canada
Completed
Brampton, L6T 0G1, Canada
Completed
Sarnia, N7T 4X3, Canada
Completed
London, N5W 6A2, Canada
Completed
Etobicoke, M8V 3X8, Canada
Completed
Stayner, L0M 1S0, Canada
Completed
Toronto, M4S 1Y2, Canada
Completed
Pointe-Claire, H9R 3J1, Canada
Terminated
Ste-Foy, G1W 1S2, Canada
Terminated
Katowice, 40-040, Poland
Terminated
Wroclaw, 50-088, Poland
Terminated
Gdynia, 81-384, Poland
Terminated
Warszawa, 01-192, Poland
Terminated
Deurne, 2100, Belgium
Terminated
HAM, 3545, Belgium
Terminated
Wetteren, 9230, Belgium
Terminated
MOORSEL, 9310, Belgium
Terminated
STEENOKKERZEEL, 1820, Belgium

Primary Outcome

  • Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28
    date_rangeTime Frame:
    From the time of first study drug administration up to Week 28
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
    date_rangeTime Frame:
    From the time of first study drug administration up to Week 28
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)
    date_rangeTime Frame:
    From the time of first study drug administration up to Week 52/EOS
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
    date_rangeTime Frame:
    From the time of study treatment up to Week 52/EOS
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of Subjects With Clinically Relevant Changes in Laboratory Parameters
    date_rangeTime Frame:
    Baseline (Week 0) up to Week 52/EOS
    enhanced_encryption
    Safety Issue:
    Yes
  • Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52
    date_rangeTime Frame:
    Baseline (Week 0), Weeks 28 and 52
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52
    date_rangeTime Frame:
    Baseline (Week 0), Weeks 28 and 52
    enhanced_encryption
    Safety Issue:
    No
  • Blood Pressure Control Rate at Weeks 28 and 52
    date_rangeTime Frame:
    Weeks 28 and 52
    enhanced_encryption
    Safety Issue:
    No
  • Blood Pressure Response Rate at Weeks 28 and 52
    date_rangeTime Frame:
    Weeks 28 and 52
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

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