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