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

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.

Timeline

Start

2007-01

Primary completion

2008-09

Completion

2008-09

Outcome

Missed primary endpoint

registry 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) vs 1.5 mg MPA / 0.3 mg CEE (Prempro); p = 0.1182 NCT00420342 ↗

registry 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) vs 1.5 mg MPA / 0.3 mg CEE (Prempro); p = 0.0702 NCT00420342 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	17ß-estradiol	Unknown	1 mg	—
Comparator	conjugated equine estrogen	Unknown	0.3 mg	—
Subject	drospirenone	Unknown	0.5 mg	—
Subject	drospirenone	Unknown	2 mg	—
Comparator	medroxyprogesterone acetate	Other / unclassified	1.5 mg	—

Indications