Back to resultsEffect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Primary Purpose
Hypertension, Postmenopause
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Postmenopausal, vasomotor symptoms, essential hypertension
Eligibility Criteria
Inclusion Criteria:- Have hypertension- Are currently taking antihypertensive medications- Have had natural menopause at least 1 year prior to screening- Must require hormone therapy in the opinion of the investigator
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Arm Label
Arm 1
Arm 3
Arm 4
Arm 5
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Mean change in systolic office blood pressure measured at through
Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
Secondary Outcome Measures
Mean change in diastolic blood pressure measured at through
Mean changes in 24-hour diastolic ABPM
Mean change in daytime systolic ABPM
Mean change in daytime diastolic ABPM
Mean change in nighttime systolic ABPM
Mean change in nighttime diastolic ABPM
Mean change in systolic APBM at through
Mean change in diastolic APBM at through
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00102141
Brief Title
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg) With Placebo for a Treatment Period of 8 Weeks on Ambulatory and Office Cuff Blood Pressure in Postmenopausal Women With Stage 1 or Stage 2 Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (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
The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.
Detailed Description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Postmenopause
Keywords
Postmenopausal, vasomotor symptoms, essential hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Experimental
Arm Title
Arm 5
Arm Type
Placebo Comparator
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Intervention Description
Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Intervention Description
Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Intervention Description
Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Intervention Description
1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, given as tablets orally once daily in the morning for 8 weeks
Primary Outcome Measure Information:
Title
Mean change in systolic office blood pressure measured at through
Time Frame
After 8 weeks of treatment
Title
Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
Time Frame
After 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Mean change in diastolic blood pressure measured at through
Time Frame
After 8 weeks of treatment
Title
Mean changes in 24-hour diastolic ABPM
Time Frame
After 8 weeks of treatment
Title
Mean change in daytime systolic ABPM
Time Frame
After 8 weeks of treatment
Title
Mean change in daytime diastolic ABPM
Time Frame
After 8 weeks of treatment
Title
Mean change in nighttime systolic ABPM
Time Frame
After 8 weeks of treatment
Title
Mean change in nighttime diastolic ABPM
Time Frame
After 8 weeks of treatment
Title
Mean change in systolic APBM at through
Time Frame
After 8 weeks of treatment
Title
Mean change in diastolic APBM at through
Time Frame
After 8 weeks of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- Have hypertension- Are currently taking antihypertensive medications- Have had natural menopause at least 1 year prior to screening- Must require hormone therapy in the opinion of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
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