Trial Condition(s):
Hypertension
High Dose BAYA1040 CR: a long term extension study
Bayer Identifier:
14023
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable
Exclusion Criteria
- Patients with expected difficulties for the continuous 1 year follow up
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Kihara Cardiovascular and Internal Hospital Asahikawa, Japan, 078-8214 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kunimoto Hospital Asahikawa, Japan, 070-0061 | Status Completed | Contact Us: E-mail: [email protected]com Phone: Not Available |
Locations Shinsapporo Seiryo Hospital Sapporo, Japan, 004-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maruyama Rira Clinic Sapporo, Japan, 064-0803 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Close To You EST Clinic Hirosaki, Japan, 036-8082 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shinagawa East One Medical Clinic Minato, Japan, 108-0075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pedi-Shiodome Clinic Minato, Japan, 105-7390 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nishimura Internal Cardiovascular Clinic Meguro, Japan, 152-0031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NS Clinic Hachioji, Japan, 192-0046 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Koukan Clinic Kawasaki, Japan, 210-0852 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nozaki Tokushukai Hospital Daito, Japan, 574-0074 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saino Clinic Tokorozawa, Japan, 359-1141 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Riverside Clinic Sapporo, Japan, 064-0807 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Toei Hospital sapporo, Japan, 007-0841 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yoshida Memorial Hospital Sapporo, Japan, 003-0026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sapporo Century Hospital Sapporo, Japan, 003-0825 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kitano-dori Internal medicine and Cardiovascular medicine CL Sapporo, Japan, 062-0053 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kotoni Medical Support Clinic Sapporo, Japan, 063-0841 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kamagaya General Hospital Kamagaya, Japan, 273-0100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Tokushukai Hospital Shizuoka, Japan, 421-0193 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yao Tokushukai General Hospital Yao, Japan, 581-0011 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multicenter, open label, long term extension study of oral BAYA1040 CR 80 mg (40 mg bid) for 44 weeks in patients with essential hypertension (extension from Study 13176)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events collectionTimeframe: Week 52
Secondary Outcome
- Changes from baseline in diastolic blood pressure (DBP) while sittingTimeframe: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
- Changes from baseline in systolic blood pressure (SBP) while sittingTimeframe: 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 guidelinesTimeframe: 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 DBPTimeframe: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
Additional Information
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