NCT00422461

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for phase_2 hypertension

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

February 27, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2008

Completed
13.7 years until next milestone

Results Posted

Study results publicly available

October 11, 2021

Completed
Last Updated

October 11, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

January 12, 2007

Results QC Date

September 13, 2021

Last Update Submit

September 13, 2021

Conditions

Hypertension

Keywords

Clinical TrialRandomized Controlled TrialHumansCyclic Nucleotide Phosphodiesterases Type 5

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) as Measured by Ambulatory Blood Pressure Monitoring (ABPM) at 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.

    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

Secondary Outcomes (10)

  • 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

  • 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

  • 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

  • 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 Cuff SBP and DBP at Day 31

    Baseline (pre dose value on Day 1 of treatment), Day 31

  • +5 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: placebo

PF-00489791 20 mg titrated to 40 mg

EXPERIMENTAL
Drug: PF-00489791

PF-00489791 4 mg

EXPERIMENTAL
Drug: PF-00489791

PF-00489791 10 mg

EXPERIMENTAL
Drug: PF-00489791

Interventions

placeboDRUG

placebo, oral, tablets, once daily, for 28 days

Placebo
PF-00489791DRUG

PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days

PF-00489791 20 mg titrated to 40 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and/or Females of non-childbearing potential between 18 and 70 years of age
  • History of mild to moderate hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

National Research Institute

Los Angeles, California, 90057, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030-3940, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Andres Patron, DO, PA

Pembroke Pines, Florida, 33026, United States

Location

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, 42431, United States

Location

Twin Cities Clinical Research

Brooklyn Center, Minnesota, 55430, United States

Location

Riser Medical Associates

Picayune, Mississippi, 39466, United States

Location

Midwest Internists Clinical Research, P.C.

St Louis, Missouri, 63141, United States

Location

Triangle Medical Research Associates, LLC

Cary, North Carolina, 27518, United States

Location

Medical Research Associates of Charlotte, Inc

Charlotte, North Carolina, 28277, United States

Location

Triangle Medical Research Associates

Raleigh, North Carolina, 27609, United States

Location

Triangle Medical Research

Raleigh, North Carolina, 27609, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Sterling Research Group limited

Cincinnati, Ohio, 45246, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Clinical Research Associates Incorporated

Nashville, Tennessee, 37203, United States

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

PF-00489791

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 17, 2007

Study Start

February 27, 2007

Primary Completion

January 28, 2008

Study Completion

January 28, 2008

Last Updated

October 11, 2021

Results First Posted

October 11, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

More information

Locations

US(20)