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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Greenville, United States, 29615 | Status Completed | Contact Us: E-mail: clinical[email protected] Phone: Not Available |
Locations Investigative Site Coral Gables, United States, 33114-4192 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37203 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salt Lake City, United States, 84121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45224 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salt Lake City, United States, 84109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90057 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30338 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rapid City, United States, 57702 | Status Completed | Contact Us: E-mail: clinical-trials-co[email protected] Phone: Not Available |
Locations Investigative Site Valparaiso, United States, 46383 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newton, United States, 67114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wichita, United States, 67205 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Orleans, United States, 70119 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auburn, United States, 04240 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kenosha, United States, 53142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75230 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hollywood, United States, 33083 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hallandale Beach, United States, 33009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shelby, United States, 28150 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampa, United States, 33606 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45245 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jupiter, United States, 33458 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Carrollton, United States, 75010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Tazewell, United States, 37825 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mt. Pleasant, United States, 29464 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lexington, United States, 40504 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32216 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beaumont, United States, 77701 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Foley, United States, 36535 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43213 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Carmichael, United States, 95608 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63141 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Elkridge, United States, 21075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milford, United States, 06460 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brockton, United States, 02301 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spring Valley, United States, 91978 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bryan, United States, 77802 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12627 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bochum, Germany, 44787 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60313 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Görlitz, Germany, 02826 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Magdeburg, Germany, 39104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Coventry, United Kingdom, CV6 4DD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Blackpool, United Kingdom, FY3 7EN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bath, United Kingdom, BA3 2UH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bury St Edmonds, United Kingdom, IP30 9QU | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United Kingdom, S40 4AA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chorley, United Kingdom, PR7 7NA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M15 6SX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Liverpool, United Kingdom, L22 0LG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cardiff, United Kingdom, CF14 5GJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B15 2SQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glasgow, United Kingdom, G20 OSP | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reading, United Kingdom, RG2 0TG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newmarket, Canada, L3Y 5G8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burlington, Canada, L7M 4Y1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burnaby, Canada, V5G 1T4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V5Z 1K3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Langley, Canada, V3A 4H9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M9V 4B4 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woodstock, Canada, N4S 4G3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brampton, Canada, L6T 0G1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sarnia, Canada, N7T 4X3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N5W 6A2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Etobicoke, Canada, M8V 3X8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stayner, Canada, L0M 1S0 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4S 1Y2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pointe-Claire, Canada, H9R 3J1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ste-Foy, Canada, G1W 1S2 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Katowice, Poland, 40-040 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50-088 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gdynia, Poland, 81-384 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 01-192 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Deurne, Belgium, 2100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HAM, Belgium, 3545 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wetteren, Belgium, 9230 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MOORSEL, Belgium, 9310 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site STEENOKKERZEEL, Belgium, 1820 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28Timeframe: From the time of first study drug administration up to Week 28
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28Timeframe: From the time of first study drug administration 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)Timeframe: From the time of first study drug administration up to Week 52/EOS
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)Timeframe: From the time of study treatment up to Week 52/EOS
Secondary Outcome
- Number of Subjects With Clinically Relevant Changes in Laboratory ParametersTimeframe: Baseline (Week 0) up to Week 52/EOS
- Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52Timeframe: Baseline (Week 0), Weeks 28 and 52
- Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52Timeframe: Baseline (Week 0), Weeks 28 and 52
- Blood Pressure Control Rate at Weeks 28 and 52Timeframe: Weeks 28 and 52
- Blood Pressure Response Rate at Weeks 28 and 52Timeframe: Weeks 28 and 52
Additional Information
Copyright © Bayer
Powered by
