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

Condition(s) targeted: Prehypertension; High Blood Pressure

Intervention: 0.5 mg drospirenone/1.0 mg 17 beta-estradiol (Drug); 2.0 mg drospirenone/1.0 mg 17 beta-estradiol (Drug); 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated estrogen (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Berlex Inc., Medical Affairs, Study Director, Affiliation: 1888-BERLEX-4

Overall contact:
Berlex Inc., Medical Affairs, Phone: 1888-BERLEX-4

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of prehypertension. The study will investigate the effects of drospirenone/estradiol (Angeliq®) and medroxyprogesterone acetate/conjugated equine estrogen (Prempro™) on blood pressure and sodium sensitivity in postmenopausal women with prehypertension.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Mean change from baseline in systolic ambulatory blood pressure

Secondary outcome:

Systolic and diastolic office cuff blood pressure at trough

Mean systolic and diastolic ambulatory blood pressure at daytime, nighttime, and trough

24 hour diastolic ambulatory blood pressure and body weight

24 hour sodium excretion and office cuff blood pressure by the sodium sensitivity subjects

Detailed description: Number of arms: 3

1. SH K 00641 A - Drospirenone / Estradiol (Angeliq) - Active study medication encapsulated

tablet

2. SH K 00641 B - Drospirenone / Estradiol (Angeliq) - Active study medication encapsulated

tablet

3. SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) - Active

control encapsulated tablet

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.

Minimum age: 45 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal women 45 - 65 years old with prehypertension

Exclusion Criteria:

- Hormone therapy (estrogen/progestin)

Berlex Inc., Medical Affairs, Phone: 1888-BERLEX-4

San Diego, California, United States; Recruiting

Miami, Florida, United States; Not yet recruiting

Daytona Beach, Florida, United States; Not yet recruiting

Las Vegas, Nevada, United States; Not yet recruiting

Philadelphia, Pennsylvania, United States; Recruiting

Columbia, South Carolina, United States; Recruiting

Arlington, Virginia, United States; Not yet recruiting

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Starting date: January 2007
Last updated: July 17, 2007