check_circleStudy Completed

Postmenopause, Hypertension, Pre-Hypertension

Bayer Identifier:

91507

ClinicalTrials.gov Identifier:

NCT00420342

EudraCT Number:

Not Available

EU CT Number:

Not Available
Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

Trial 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.

Key Participants Requirements

Sex

Female

Age

45 - 65 Years
  • - Postmenopausal women 45 - 65 years old with prehypertension
  • - Hormone therapy (estrogen/progestin)

Trial summary

Enrollment Goal
92
Trial Dates
January 2007 - September 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Angeliq (E2/DRSP, BAY86-4891)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
University of MiamiMiami, 33136, United States
Completed
Clinical Research of Philadelphia, LLCPhiladelphia, 19114, United States
Completed
Atlantic Institute of Clinical ResearchDaytona Beach, 32114, United States
Completed
Marin Endocrine AssociatesGreenbrae, 94904, United States
Completed
Dr. Yekaterina Khronusova, MDLas Vegas, 89122, United States
Completed
South Carolina Clinical Research CenterColumbia, 29201, United States
Completed
Millennium Clinical Research CenterArlington, 22203, United States
Completed
Women's Health Care SpecialistPaw Paw, 49079, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    Baseline to Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population
    date_rangeTime Frame:
    Baseline to Week 8
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

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

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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