Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00420342
First received: January 9, 2007
Last updated: April 22, 2014
Last verified: April 2014
  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: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)
Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
Phase 2

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


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 ]
    The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP.

  • 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 ]
    The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP.


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 ]
    The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.

  • 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 ]
    Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.

  • 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 ]
    Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)

  • 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 ]
    Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle)

  • Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 [ Time Frame: 8 weeks plus 3 days ] [ Designated as safety issue: No ]
    Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported.

  • 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 ]
    Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.

  • 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 ]
    Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.

  • 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 ]
    Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.

  • 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 ]
    Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.

  • 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 ]
    Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg.


Enrollment: 92
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)
SH K 00641 A -Active study medication encapsulated tablet
Experimental: 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)
2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Drug: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)
SH K 00641 B - Active study medication encapsulated tablet
Active Comparator: 1.5 mg MPA / 0.3 mg CEE (Prempro)
1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Greenbrae, California, United States, 94904
San Diego, California, United States, 92108
United States, Florida
Daytona Beach, Florida, United States, 32114
Miami, Florida, United States, 33136
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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00420342     History of Changes
Other Study ID Numbers: 91507, 310522
Study First Received: January 9, 2007
Results First Received: October 28, 2009
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Pre-Hypertension in Postmenopausal Women

Additional relevant MeSH terms:
Hypertension
Prehypertension
Cardiovascular Diseases
Vascular Diseases
Drospirenone
Drospirenone and ethinyl estradiol combination
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Medroxyprogesterone
Medroxyprogesterone Acetate
Polyestradiol phosphate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Diuretics
Diuretics, Potassium Sparing
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014