Phase 2 N=92 Randomized Double-blind Treatment

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

Postmenopause · Hypertension · Pre-Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00420342 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcome: Primary: 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 — -1.03; -0.27; 2.18 mmHg — p=0.1182

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) (Drug); SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	-1.03; -0.27; 2.18	0.1182
PRIMARY Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population	-1.08; 0.06; 2.82	0.0702
SECONDARY Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements	-1.19; -0.91; 0.57	—
SECONDARY Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough	-5.25; -6.02; -4.20; -1.34; -0.36; 0.33	—
SECONDARY Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements	-2.08; -1.06; 1.53; 1.57; 1.64; 3.97	—
SECONDARY Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements	-1.95; -1.56; 0.17; 0.20; 0.67; 1.75	—
SECONDARY Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8	4; 3; 4; 1; 2; 2	—
SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)	-1.9; -1.9; 1.4	—
SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)	-2.4; -2.2; 2.0	—
SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)	-2.6; -3.7; 1.1	—
SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)	-3.4; -4.4; 1.1	—
SECONDARY Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)	-5.2; -4.0; 1.0	—

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.

Eligibility Criteria

Inclusion Criteria

Postmenopausal women 45 - 65 years old with prehypertension

Exclusion Criteria

Hormone therapy (estrogen/progestin)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00420342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.