High Dose BAYA1040 CR: a Long Term Extension Study
- Registration Number
- NCT01355367
- Lead Sponsor
- Bayer
- Brief Summary
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040 CR 80 mg/day (40 mg twice daily) in patients with essential hypertension for whom the test drug is tolerable during the 8 week double blind treatment phase of Study 13176.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable
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Exclusion Criteria
- Patients with expected difficulties for the continuous 1 year follow up
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Nifedipine (Adalat, BAYA1040) -
- Primary Outcome Measures
Name Time Method Safety variables will be summarized using descriptive statistics based on adverse events collection Week 52
- Secondary Outcome Measures
Name Time Method Changes from baseline in diastolic blood pressure (DBP) while sitting Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 Changes from baseline in systolic blood pressure (SBP) while sitting Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52 Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52