High Dose BAYA1040_Nifedipine: a Dose-comparative Study
- Registration Number
- NCT01287260
- Lead Sponsor
- Bayer
- Brief Summary
This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
Inclusion Criteria
- 20 years or older
- Japanese male or female
- Outpatient with essential hypertension
- Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug
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Exclusion Criteria
- Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more
- Patients with secondary hypertension or hypertensive emergency
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm1 Nifedipine (Adalat, BAYA1040) - Arm 2 Nifedipine (Adalat, BAYA1040) -
- Primary Outcome Measures
Name Time Method Efficacy changes measured by sitting diastolic blood pressure (DBP) Up to 8 weeks
- Secondary Outcome Measures
Name Time Method Efficacy changes measured by sitting systolic blood pressure (SBP) Up to 8 weeks Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines Up to 8 weeks Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP Up to 8 weeks