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

• ClinicalTrials.gov Identifier: NCT00420342
• Recruitment Status: Completed
• First Posted: January 11, 2007
• Results First Posted: January 20, 2010
• Last Update Posted: June 2, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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 or disease	Intervention/treatment	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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: January 2007
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.
2. 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 ]
   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 :

1. Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements [ Time Frame: Baseline to Week 8 ]
   The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set.
2. Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough [ Time Frame: Baseline to Week 8 ]
   Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint.
3. 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 ]
   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)
4. 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 ]
   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)
5. Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 [ Time Frame: 8 weeks plus 3 days ]
   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.
6. 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 ]
   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.
7. 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 ]
   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.
8. 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 ]
   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.
9. 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 ]
   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.
10. 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 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 65 Years (Adult, Older Adult)
• Sexes 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

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

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00420342
• Other Study ID Numbers: 91507; 310522 ( Other Identifier: Company internal )
• First Posted: January 11, 2007
• Results First Posted: January 20, 2010
• Last Update Posted: June 2, 2015
• Last Verified: May 2015

Keywords provided by Bayer:

Pre-Hypertension in Postmenopausal Women

Additional relevant MeSH terms:

Hypertension; Prehypertension; Vascular Diseases; Cardiovascular Diseases; Medroxyprogesterone Acetate; Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol; Polyestradiol phosphate; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Contraceptives, Oral; Contraceptives, Oral, Synthetic; Contraceptive Agents, Male; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Diuretics, Potassium Sparing