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

This study has been completed.

Study NCT00420342 Information provided by Bayer

First Received on January 9, 2007. Last Updated on April 29, 2011 History of Changes

Results First Received: October 28, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Postmenopause Hypertension Pre-Hypertension
Interventions:	Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) Drug: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject enrollment began on 16-Jan-2007 and lasted over a period of 6 months at 10 study centers in the U.S. There was no enrollment at 2 sites (108 and 110). Site 102 enrolled 14 subjects and site 105 enrolled 56 subjects (28 of whom consented to the sodium sensitivity analysis). All other sites enrolled 7 or fewer subjects.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening involved office cuff BP measurements at 3 visits to evaluate prehypertension. Of the 178 enrolled, 86 subjects were screen failures. The full analysis and safety sets had 90 subjects who took at least 1 dose of study medication (2 subjects did not confirm if they ever took the study medication).

Reporting Groups

	Description
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)
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)
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)

Participant Flow: Overall Study

	0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)	2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)	1.5 mg MPA / 0.3 mg CEE (Prempro)
STARTED	30	33	29
Received Treatment	29 ^[1]	32 ^[1]	29
COMPLETED	29	31	28
NOT COMPLETED	1	2	1
Lost to Follow-up	1	0	1
Withdrawal by Subject	0	2	0

[1]	1 subject did not confirm if she ever took the study medication.

Baseline Characteristics

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Reporting Groups

	Description
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)
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)
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)

Baseline Measures

	0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)	2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)	1.5 mg MPA / 0.3 mg CEE (Prempro)	Total
Number of Participants [units: participants]	29	32	29	90
Age [units: years] Mean ± Standard Deviation	56.3 ± 4.6	54.6 ± 5.6	54.1 ± 4.5	55.0 ± 5.0
Gender [units: participants]
Female	29	32	29	90
Male	0	0	0	0
Race/Ethnicity, Customized [units: participants]
Black / African American	3	1	1	5
White	9	12	9	30
Hispanic	17	19	19	55
Smoking history ^[1] [units: participants]
no	24	24	25	73
yes	5	8	4	17
Baseline ambulatory blood pressure ^[2] [units: mmHg] Mean ± Standard Deviation
systolic blood pressure (SBP)	121.4 ± 7.6	120.9 ± 10.4	122.1 ± 11.6	121.4 ± 9.9
diastolic blood pressure (DBP)	72.4 ± 6.7	73.1 ± 7.6	73.9 ± 8.0	73.1 ± 7.4
Baseline cuff blood pressure ^[3] [units: mmHg] Mean ± Standard Deviation
systolic blood pressure (SBP)	133.6 ± 3.2	134.3 ± 2.1	133.7 ± 2.4	133.9 ± 2.6
diastolic blood pressure (DBP)	81.5 ± 4.7	81.7 ± 4.0	80.3 ± 5.7	81.2 ± 4.8
Body Mass Index (BMI) ^[4] [units: Kg/m²] Mean ± Standard Deviation	29.1 ± 5.2	27.6 ± 4.4	27.9 ± 3.4	28.2 ± 4.4

[1]	Subjects smoking more than 10 cigarettes per day were excluded from the study.
[2]	24-hour mean Ambulatory blood pressure monitoring (ABPM) values at the Baseline visit.
[3]	The baseline SBP was to be between 130 and 139 mmHg and DBP ≤ 89 mmHg. The mean SBP values from 2 of the 3 consecutive office cuff measurements during the screening visits were to have been within 12 mmHg and the mean DBP values within 8 mmHg to confirm stability of the blood pressure.
[4]	Height, body weight, and arm circumference were measured at the screening visit and body weight was measured at the screening, treatment phase, and follow-up visits. The same scale was used for all body weight measurements. BMI was measured in kg/m².

Outcome Measures

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1. 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 [ Time Frame: Baseline to Week 8 ]

Show Outcome Measure 1

2. Primary:

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 ]

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3. Secondary:

Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements [ Time Frame: Baseline to Week 8 ]

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4. Secondary:

Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough [ Time Frame: Baseline to Week 8 ]

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5. Secondary:

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 ]

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6. Secondary:

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 ]

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7. Secondary:

Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8 [ Time Frame: 8 weeks plus 3 days ]

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8. Secondary:

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 ]

Show Outcome Measure 8

9. Secondary:

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 ]

Show Outcome Measure 9

10. Secondary:

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 ]

Show Outcome Measure 10

11. Secondary:

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 ]

Show Outcome Measure 11

12. Secondary:

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 ]

Show Outcome Measure 12

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: (A). PI will provide copy to Sponsor sixty (60) days. Sponsor will have thirty (30) days to review and provide feedback. (B). If proposed publication presents material adverse effect on Sponsor's confidentiality information, then PI shall delay or prevent such publication. (C) In multi-center trial, the investigative data will be pooled and published as a collaborative effort with consent from all parties including the Sponsor.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size, as this was a pilot study.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.
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 29, 2011
Health Authority:	United States: Food and Drug Administration