check_circleStudy Completed
Hypertension
Bayer Identifier:
13176
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
High Dose BAYA1040_Nifedipine: a dose-comparative study
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
20 - N/ATrial summary
Enrollment Goal
352Trial Dates
January 2011 - August 2011Phase
Phase 3Could I Receive a placebo
NoProducts
Adalat CC (Nifedipine, BAYA1040)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kihara Cardiovascular and Internal Hospital | Asahikawa, 078-8214, Japan |
Completed | Kunimoto Hospital | Asahikawa, 070-0061, Japan |
Completed | Shinsapporo Seiryo Hospital | Sapporo, 004-0004, Japan |
Completed | Maruyama Rira Clinic | Sapporo, 064-0803, Japan |
Completed | Close To You EST Clinic | Hirosaki, 036-8082, Japan |
Completed | Shinagawa East One Medical Clinic | Minato, 108-0075, Japan |
Completed | Pedi-Shiodome Clinic | Minato, 105-7390, Japan |
Completed | Nishimura Internal Cardiovascular Clinic | Meguro, 152-0031, Japan |
Completed | NS Clinic | Hachioji, 192-0046, Japan |
Completed | Koukan Clinic | Kawasaki, 210-0852, Japan |
Completed | Nozaki Tokushukai Hospital | Daito, 574-0074, Japan |
Completed | Kishiwada Tokushukai Hospital | Kishiwada, 596-8522, Japan |
Terminated | Saino Clinic | Tokorozawa, 359-1141, Japan |
Completed | Riverside Clinic | Sapporo, 064-0807, Japan |
Completed | Toei Hospital | sapporo, 007-0841, Japan |
Completed | Yoshida Memorial Hospital | Sapporo, 003-0026, Japan |
Completed | Sapporo Century Hospital | Sapporo, 003-0825, Japan |
Completed | Kitano-dori Internal medicine and Cardiovascular medicine CL | Sapporo, 062-0053, Japan |
Completed | Kotoni Medical Support Clinic | Sapporo, 063-0841, Japan |
Completed | Kamagaya General Hospital | Kamagaya, 273-0100, Japan |
Completed | Shizuoka Tokushukai Hospital | Shizuoka, 421-0193, Japan |
Completed | Yao Tokushukai General Hospital | Yao, 581-0011, Japan |
Primary Outcome
- Efficacy changes measured by sitting diastolic blood pressure (DBP)date_rangeTime Frame:Up to 8 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Efficacy changes measured by sitting systolic blood pressure (SBP)date_rangeTime Frame:Up to 8 weeksenhanced_encryptionNoSafety Issue:
- Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelinesdate_rangeTime Frame:Up to 8 weeksenhanced_encryptionNoSafety Issue:
- Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBPdate_rangeTime Frame:Up to 8 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2