A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY OF PF-00489791 IN SUBJECTS WITH STAGE 1 AND 2 ESSENTIAL HYPERTENSION USING AMBULATORY BLOOD PRESSURE MONITORING (ABPM)
Overview
- Phase
- Phase 2
- Intervention
- placebo
- Conditions
- Hypertension
- Sponsor
- Pfizer
- Enrollment
- 135
- Locations
- 20
- Primary Endpoint
- Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and blood pressure lowering effect of different doses of PF-00489791 in patients with mild to moderate high blood pressure
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and/or Females of non-childbearing potential between 18 and 70 years of age
- •History of mild to moderate hypertension
Exclusion Criteria
- •Type 1 or 2 diabetes on prescribed medications
- •Secondary, severe, or malignant hypertension
- •History of a significant cardiovascular event within the last 12 months of enrollment
Arms & Interventions
Placebo
Intervention: placebo
PF-00489791 20 mg titrated to 40 mg
Intervention: PF-00489791
PF-00489791 4 mg
Intervention: PF-00489791
PF-00489791 10 mg
Intervention: PF-00489791
Outcomes
Primary Outcomes
Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at Day 28
Time Frame: From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28
The ABPM device was automatically programmed to inflate at every 20 minutes from 05:00 until 21:59 hours and from 22:00 to 04:59 hours the device inflated every 60 minutes. 24-hour clock time was used. ABPM was performed in this study on Baseline, Day 1, 14 and 28. Mean daytime SBP was an average of SBP measurements taken between 08:00 and 16:00 hours by ABPM device on the specified time points. In this outcome measure change from baseline in mean daytime SBP at Day 28 is reported.
Secondary Outcomes
- Change From Baseline in Cuff SBP and DBP at Day 28(Baseline (pre dose value on Day 1 of treatment), Day 28)
- Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) as Measured by ABPM at Day 28(From 08:00 to 16:00 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28)
- Minimum and Maximum SBP and DBP as Measured by ABPM Over 24 Hours on Baseline, Day 1, 14 and 28(Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug), Day 1, 14 and 28)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Day 1 up to 14 days after last dose of study drug (maximum up to 42 days))
- Change From Baseline in Heart Rate at Baseline, Day 1, 7, 14, 21, 28 and 31(Baseline (pre dose value on Day 1 of treatment), Day 1, 7, 14, 21, 28, 31)
- Change From Baseline in Mean 24-Hour SBP and DBP as Measured by ABPM at Day 28(Over 24 hours on Baseline (Day 0, 1 day prior to first double-blind dose of study drug) and Day 28)
- Change From Baseline in Cuff Mean Arterial Pressure (MAP) at Day 28(Baseline (pre dose value on Day 1 of treatment), Day 28)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Day 1 up to 14 days after last dose of study drug (maximum up to 42 days))
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings(Day 1 up to 14 days after last dose of study drug (maximum up to 42 days))
- Change From Baseline in Cuff SBP and DBP at Day 31(Baseline (pre dose value on Day 1 of treatment), Day 31)