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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00420342 |
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro185 on blood pressure in post-menopausal women with prehypertension.
Condition | Intervention | Phase |
---|---|---|
Pre-Hypertension High Blood Pressure |
Drug: SH K 00641 A - Drospirenone / Estradiol (Angeliq) Drug: SH K 00641 B - Drospirenone / Estradiol (Angeliq) Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 (Prempro185) on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension |
Enrollment: | 90 |
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 |
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Arm 1: Active Comparator |
Drug: SH K 00641 A - Drospirenone / Estradiol (Angeliq)
Active study medication encapsulated tablet
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Arm 2: Active Comparator |
Drug: SH K 00641 B - Drospirenone / Estradiol (Angeliq)
Active study medication encapsulated tablet
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Arm 3: Active Comparator |
Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
Active control encapsulated tablet
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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.
Ages Eligible for Study: | 45 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 91507, 310522 |
Study First Received: | January 9, 2007 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00420342 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prehypertension in Postmenopausal Women |
Medroxyprogesterone 17-Acetate Estrogens Antineoplastic Agents, Hormonal Contraceptive Agents Benzoates Hormone Antagonists Contraceptives, Oral Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases |
Estradiol 17 beta-cypionate Contraceptive Agents, Male Hormones Estradiol Estrogens, Conjugated (USP) Aldosterone Antagonists Estradiol 3-benzoate Drospirenone Medroxyprogesterone Polyestradiol phosphate Hypertension |
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 |