High Dose BAYA1040_Nifedipine: a Long Term Combination Study
A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension
1 other identifier
interventional
72
1 country
4
Brief Summary
This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040\_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040\_Nifedipine 40 mg once daily and other antihypertensives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Feb 2011
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJune 23, 2014
June 1, 2014
9 months
February 10, 2011
June 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy changes measured by sitting diastolic blood pressure (DBP)
Up to 52 weeks
Secondary Outcomes (4)
Efficacy changes measured by sitting systolic blood pressure (SBP)
Up to 52 weeks
Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
Up to 52 weeks
Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
Up to 52 weeks
Safety variables
Up to 30 days after the last dose of study drug
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- years or older
- Japanese male or female
- Outpatient with essential hypertension
- Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study
You may not qualify if:
- Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
- Patients with secondary hypertension or hypertensive emergency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (4)
Unknown Facility
Ebina, Kanagawa, 243-0401, Japan
Unknown Facility
Sagamihara, Kanagawa, 252-0311, Japan
Unknown Facility
Kawaguchi, Saitama, 332-0012, Japan
Unknown Facility
Shinjuku, Tokyo, 169-0072, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
February 1, 2011
Primary Completion
November 1, 2011
Study Completion
June 1, 2012
Last Updated
June 23, 2014
Record last verified: 2014-06