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Completed

NCT Number: NCT00420342

Effects of Angeliq and Prempro 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 Prempro on blood pressure in post-menopausal women with prehypertension.

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Key information

Conditions

Postmenopause Cardiovascular Diseases Hypertension Pre-Hypertension Prehypertension Vascular Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Greenbrae, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women 45 - 65 years old with prehypertension

Exclusion criteria

  • Hormone therapy (estrogen/progestin)

Treatment and study plan

Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)

Drug

SH K 00641 A -Active study medication encapsulated tablet

SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)

Drug

Active control encapsulated tablet

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 11, 2007
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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