NCT00420342

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Postmenopause
• Hypertension
• Pre-Hypertension

Interventions

Type	Name	Description
DRUG	Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)	SH K 00641 A -Active study medication encapsulated tablet
DRUG	Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)	SH K 00641 B - Active study medication encapsulated tablet
DRUG	SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)	Active control encapsulated tablet

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-01-11
• Last updated: 2015-06-02
• Results posted: 2010-01-20

Locations

9 sites across 1 country: United States