Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

Study Overview
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Brief Summary
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The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.

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 Double Blind, Randomized, Active-control Study to Evaluate Effects of Drospirenone/Estradiol (Angeliq) and Medroxyprogesterone Acetate/Conjugated Equine Estrogen (Prempro) on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

Conditions
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Postmenopause, Hypertension, Pre-Hypertension

Intervention / Treatment
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* Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)
* Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)
* Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Postmenopausal women 45 - 65 years old with prehypertension Exclusion Criteria: - Hormone therapy (estrogen/progestin)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)<br>0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)<br>* SH K 00641 A -Active study medication encapsulated tablet<br>|
| Experimental: 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)<br>2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)<br>* SH K 00641 B - Active study medication encapsulated tablet<br>|
| Active Comparator: 1.5 mg MPA / 0.3 mg CEE (Prempro)<br>1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) | Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)<br>* Active control encapsulated tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population | The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP. | Baseline to Week 8 | 
| Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population | The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP. | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements | The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set. | Baseline to Week 8 | 
| Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough | Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint. | Baseline to Week 8 | 
| Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements | Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle) | Baseline to Week 8 | 
| Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements | Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle) | Baseline to Week 8 | 
| Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 | Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported. | 8 weeks plus 3 days | 
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | Baseline to Week 8 | 
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | Baseline to Week 8 | 
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | Baseline to Week 8 | 
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | Baseline to Week 8 | 
| Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) | Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. | Baseline to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-Hypertension in Postmenopausal Women