Trial Condition(s):
Hypertension
High Dose BAYA1040_Nifedipine: a dose-comparative study
Bayer Identifier:
13176
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Kihara Cardiovascular and Internal Hospital Asahikawa, Japan, 078-8214 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kunimoto Hospital Asahikawa, Japan, 070-0061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shinsapporo Seiryo Hospital Sapporo, Japan, 004-0004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maruyama Rira Clinic Sapporo, Japan, 064-0803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Close To You EST Clinic Hirosaki, Japan, 036-8082 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shinagawa East One Medical Clinic Minato, Japan, 108-0075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pedi-Shiodome Clinic Minato, Japan, 105-7390 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nishimura Internal Cardiovascular Clinic Meguro, Japan, 152-0031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NS Clinic Hachioji, Japan, 192-0046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Koukan Clinic Kawasaki, Japan, 210-0852 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nozaki Tokushukai Hospital Daito, Japan, 574-0074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saino Clinic Tokorozawa, Japan, 359-1141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Riverside Clinic Sapporo, Japan, 064-0807 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Toei Hospital sapporo, Japan, 007-0841 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yoshida Memorial Hospital Sapporo, Japan, 003-0026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sapporo Century Hospital Sapporo, Japan, 003-0825 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kitano-dori Internal medicine and Cardiovascular medicine CL Sapporo, Japan, 062-0053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kotoni Medical Support Clinic Sapporo, Japan, 063-0841 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kamagaya General Hospital Kamagaya, Japan, 273-0100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Tokushukai Hospital Shizuoka, Japan, 421-0193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yao Tokushukai General Hospital Yao, Japan, 581-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Efficacy changes measured by sitting diastolic blood pressure (DBP)Timeframe: Up to 8 weeks
Secondary Outcome
- Efficacy changes measured by sitting systolic blood pressure (SBP)Timeframe: Up to 8 weeks
- Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelinesTimeframe: 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 DBPTimeframe: Up to 8 weeks
Additional Information
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