- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355367
High Dose BAYA1040 CR: a Long Term Extension Study
January 28, 2014 updated by: Bayer
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shizuoka, Japan, 421-0193
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Aomori
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Hirosaki, Aomori, Japan, 036-8082
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Chiba
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Kamagaya, Chiba, Japan, 273-0100
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Hokkaido
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Asahikawa, Hokkaido, Japan, 078-8214
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Asahikawa, Hokkaido, Japan, 070-0061
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Sapporo, Hokkaido, Japan, 064-0807
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Sapporo, Hokkaido, Japan, 007-0841
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Sapporo, Hokkaido, Japan, 003-0026
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Sapporo, Hokkaido, Japan, 003-0825
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Sapporo, Hokkaido, Japan, 004-0004
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Sapporo, Hokkaido, Japan, 062-0053
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Sapporo, Hokkaido, Japan, 063-0841
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Sapporo, Hokkaido, Japan, 064-0803
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Kanagawa
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Kawasaki, Kanagawa, Japan, 210-0852
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Osaka
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Daito, Osaka, Japan, 574-0074
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Kishiwada, Osaka, Japan, 596-8522
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Yao, Osaka, Japan, 581-0011
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Saitama
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Tokorozawa, Saitama, Japan, 359-1141
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Tokyo
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Hachioji, Tokyo, Japan, 192-0046
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Meguro, Tokyo, Japan, 152-0031
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Minato, Tokyo, Japan, 105-7390
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Minato, Tokyo, Japan, 108-0075
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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BAYA1040 CR 40mg BID
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: Week 52
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Week 52
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from baseline in diastolic blood pressure (DBP) while sitting
Time Frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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Changes from baseline in systolic blood pressure (SBP) while sitting
Time Frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Time Frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Time Frame: Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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Baseline, week 10, 12, 16, 24, 28, 32, 36, 40, 44, 48 and 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
April 21, 2011
First Submitted That Met QC Criteria
May 17, 2011
First Posted (Estimate)
May 18, 2011
Study Record Updates
Last Update Posted (Estimate)
January 29, 2014
Last Update Submitted That Met QC Criteria
January 28, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Nifedipine
Other Study ID Numbers
- 14023 (Other Identifier: City of Hope Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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