Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypertension, Postmenopause

Intervention / Treatment
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* Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
* Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
* Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
* Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)<br>* Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks<br>|
| Experimental: Arm 3<br> | Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)<br>* Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks<br>|
| Experimental: Arm 4<br> | Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)<br>* 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks<br>|
| Placebo Comparator: Arm 5<br> | Drug: Placebo<br>* Placebo, given as tablets orally once daily in the morning for 8 weeks<br>|
| Experimental: Arm 2<br> | Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)<br>* Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in systolic office blood pressure measured at through |  | After 8 weeks of treatment | 
| Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM) |  | After 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in diastolic blood pressure measured at through |  | After 8 weeks of treatment | 
| Mean changes in 24-hour diastolic ABPM |  | After 8 weeks of treatment | 
| Mean change in daytime systolic ABPM |  | After 8 weeks of treatment | 
| Mean change in daytime diastolic ABPM |  | After 8 weeks of treatment | 
| Mean change in nighttime systolic ABPM |  | After 8 weeks of treatment | 
| Mean change in nighttime diastolic ABPM |  | After 8 weeks of treatment | 
| Mean change in systolic APBM at through |  | After 8 weeks of treatment | 
| Mean change in diastolic APBM at through |  | After 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal, vasomotor symptoms, essential hypertension