Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00420342

Purpose

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.

Condition	Intervention	Phase
Postmenopause Hypertension Pre-Hypertension	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 Medroxyprogesterone 17-acetate Estradiol dipropionate Prempro Estradiol cypionate Medroxyprogesterone Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 [ Time Frame: 8 weeks plus 3 days ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Enrollment:	92
Study Start Date:	January 2007
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) SH K 00641 A -Active study medication encapsulated tablet
Arm 2: Active Comparator	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) SH K 00641 B - Active study medication encapsulated tablet
Arm 3: Active Comparator	Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) Active control encapsulated tablet

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 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

- Postmenopausal women 45 - 65 years old with prehypertension

Exclusion Criteria:

- Hormone therapy (estrogen/progestin)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420342

Locations

United States, California

San Diego, California, United States, 92108

Greenbrae, California, United States, 94904
United States, Florida

Miami, Florida, United States, 33125

Daytona Beach, Florida, United States, 32114
United States, Michigan

Paw Paw, Michigan, United States, 49079
United States, Nevada

Las Vegas, Nevada, United States, 89122
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina

Columbia, South Carolina, United States, 29201
United States, Virginia

Arlington, Virginia, United States, 22203

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:	91507, 310522
Study First Received:	January 9, 2007
Results First Received:	October 28, 2009
Last Updated:	January 18, 2010
ClinicalTrials.gov Identifier:	NCT00420342 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by Bayer:

Pre-Hypertention in Postmenopausal Women

Additional relevant MeSH terms:

Medroxyprogesterone 17-Acetate
Antineoplastic Agents
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Estradiol 17 beta-cypionate
Reproductive Control Agents
Contraceptive Agents, Male
Hormones
Estrogens, Conjugated (USP)

Estradiol 3-benzoate
Therapeutic Uses
Drospirenone
Contraceptives, Oral, Synthetic
Cardiovascular Diseases
Polyestradiol phosphate
Estrogens
Antineoplastic Agents, Hormonal
Vascular Diseases
Estradiol
Pharmacologic Actions
Aldosterone Antagonists
Medroxyprogesterone
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010