Back to resultsHigh Dose BAYA1040 CR: a Long Term Extension Study
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Nifedipine (Adalat, BAYA1040)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring BAYA1040 CR, Nifedipine, Essential hypertension, Japanese Patients, Phase III, Extension study
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Safety variables will be summarized using descriptive statistics based on adverse events collection
Secondary Outcome Measures
Changes from baseline in diastolic blood pressure (DBP) while sitting
Changes from baseline in systolic blood pressure (SBP) while sitting
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01355367
Brief Title
High Dose BAYA1040 CR: a Long Term Extension Study
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
BAYA1040 CR, Nifedipine, Essential hypertension, Japanese Patients, Phase III, Extension study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nifedipine (Adalat, BAYA1040)
Intervention Description
BAYA1040 CR 40mg BID
Primary Outcome Measure Information:
Title
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8082
Country
Japan
City
Kamagaya
State/Province
Chiba
ZIP/Postal Code
273-0100
Country
Japan
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-0061
Country
Japan
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8214
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0026
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0825
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0004
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
007-0841
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
062-0053
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0841
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0803
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0807
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
City
Daito
State/Province
Osaka
ZIP/Postal Code
574-0074
Country
Japan
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-8522
Country
Japan
City
Yao
State/Province
Osaka
ZIP/Postal Code
581-0011
Country
Japan
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1141
Country
Japan
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
City
Meguro
State/Province
Tokyo
ZIP/Postal Code
152-0031
Country
Japan
City
Minato
State/Province
Tokyo
ZIP/Postal Code
105-7390
Country
Japan
City
Minato
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
City
Shizuoka
ZIP/Postal Code
421-0193
Country
Japan
12. IPD Sharing Statement
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High Dose BAYA1040 CR: a Long Term Extension Study
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