Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00102141

Purpose

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.

Condition	Intervention	Phase
Hypertension Postmenopause	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen 1,2-Dihydrospirorenone Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Mean change in systolic office blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM) [ Time Frame: After 8 weeks of treatment ]

Secondary Outcome Measures:

Mean change in diastolic blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
Mean changes in 24-hour diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in daytime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in daytime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in nighttime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in nighttime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
Mean change in systolic APBM at through [ Time Frame: After 8 weeks of treatment ]
Mean change in diastolic APBM at through [ Time Frame: After 8 weeks of treatment ]

Enrollment:	1879
Study Start Date:	April 2004
Study Completion Date:	August 2005

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Arm 3: Experimental	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Arm 4: Experimental	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
Arm 5: Placebo Comparator	Drug: Placebo Placebo, given as tablets orally once daily in the morning for 8 weeks
Arm 2: Experimental	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks

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.

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102141

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91202, 306743
Study First Received:	January 21, 2005
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00102141 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Postmenopausal
vasomotor symptoms
essential hypertension

Additional relevant MeSH terms:

Estrogens
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Vascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Estradiol 17 beta-cypionate

Hormones
Pharmacologic Actions
Estradiol
Aldosterone Antagonists
Therapeutic Uses
Estradiol 3-benzoate
Drospirenone
Cardiovascular Diseases
Polyestradiol phosphate
Hypertension

ClinicalTrials.gov processed this record on March 18, 2010