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Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102141
Recruitment Status : Completed
First Posted : January 24, 2005
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE January 21, 2005
First Posted Date  ICMJE January 24, 2005
Last Update Posted Date December 15, 2014
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
  • Mean change in systolic office blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
  • Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM) [ Time Frame: After 8 weeks of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Mean change from Baseline to Week 8 in systolic office blood pressure measured at trough and in 24-hour systolic ambulatory blood pressure measurement (ABPM) blood pressure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
  • Mean change in diastolic blood pressure measured at through [ Time Frame: After 8 weeks of treatment ]
  • Mean changes in 24-hour diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in daytime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in daytime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in nighttime systolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in nighttime diastolic ABPM [ Time Frame: After 8 weeks of treatment ]
  • Mean change in systolic APBM at through [ Time Frame: After 8 weeks of treatment ]
  • Mean change in diastolic APBM at through [ Time Frame: After 8 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Mean change from Baseline to Week 8 in diastolic office cuff blood pressure measured at trough and in 24-hour diastolic ABPM blood pressure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Official Title  ICMJE A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg) With Placebo for a Treatment Period of 8 Weeks on Ambulatory and Office Cuff Blood Pressure in Postmenopausal Women With Stage 1 or Stage 2 Essential Hypertension
Brief Summary The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Postmenopause
Intervention  ICMJE
  • Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
    Drospirenone 3 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
  • Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
    Drospirenone 2 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
  • Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
    Drospirenone 1 mg + 1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
  • Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
    1mg 17ß-estradiol, given as tablets orally once daily in the morning for 8 weeks
  • Drug: Placebo
    Placebo, given as tablets orally once daily in the morning for 8 weeks
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
  • Experimental: Arm 3
    Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
  • Experimental: Arm 4
    Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
  • Placebo Comparator: Arm 5
    Intervention: Drug: Placebo
  • Experimental: Arm 2
    Intervention: Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2014)
750
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
675
Actual Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Inclusion Criteria:- Have hypertension- Are currently taking antihypertensive medications- Have had natural menopause at least 1 year prior to screening- Must require hormone therapy in the opinion of the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Czech Republic,   Poland,   Russian Federation,   Ukraine,   United States
 
Administrative Information
NCT Number  ICMJE NCT00102141
Other Study ID Numbers  ICMJE 91202
306743
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP