NCT01287260CompletedPhase 3
A Multicenter, Double-blind, Parallel-group Comparative Study Between Oral BAYA1040_CR 80 mg and 40 mg for 8 Weeks in Patients With Essential Hypertension for Whom Oral BAYA1040_CR 40 mg is Insufficient
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 352
- Primary Endpoint
- Efficacy changes measured by sitting diastolic blood pressure (DBP)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Arm1
Experimental
Intervention: Nifedipine (Adalat, BAYA1040) (Drug)
Arm 2
Active Comparator
Intervention: Nifedipine (Adalat, BAYA1040) (Drug)
Outcomes
Primary Outcomes
Efficacy changes measured by sitting diastolic blood pressure (DBP)
Time Frame: Up to 8 weeks
Secondary Outcomes
- 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)
Investigators
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