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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

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.

Intervention(s) in this Clinical Trial

• Drug: SH K 00641 A - Drospirenone / Estradiol (Angeliq)
  • Active study medication encapsulated tablet
• Drug: SH K 00641 B - Drospirenone / Estradiol (Angeliq)
  • Active study medication encapsulated tablet
• Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
  • Active control encapsulated tablet

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2
• Active Comparator: Arm 3

Primary Measures

• Mean change from baseline in systolic ambulatory blood pressure
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Secondary Measures

• Systolic and diastolic office cuff blood pressure at trough
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• Mean systolic and diastolic ambulatory blood pressure at daytime, nighttime, and trough
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• 24 hour diastolic ambulatory blood pressure and body weight
  • Time Frame: 8 weeks
    Safety Issue?: Yes
• 24 hour sodium excretion and office cuff blood pressure by the sodium sensitivity subjects
  • Time Frame: 8 weeks plus 3 days
    Safety Issue?: Yes

Inclusion Criteria:

• Postmenopausal women 45 - 65 years old with prehypertension

Exclusion Criteria:

• Hormone therapy (estrogen/progestin)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00420342

Study ID Number: 91507

ClinicalTrials.gov Identifier: NCT00420342

Health Authority: United States: Food and Drug Administration

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