A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure

NCT ID: NCT00422461

Last Updated: 2021-10-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-27

Study Completion Date

2008-01-28

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

PF-00489791 20 mg titrated to 40 mg

Group Type EXPERIMENTAL

PF-00489791

Intervention Type DRUG

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

PF-00489791 4 mg

Group Type EXPERIMENTAL

PF-00489791

Intervention Type DRUG

PF-00489791 4 mg, oral, tablets, once daily, for 28 days

PF-00489791 10 mg

Group Type EXPERIMENTAL

PF-00489791

Intervention Type DRUG

PF-00489791 10 mg, oral, tablets, once daily, for 28 days

Interventions

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placebo

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

Intervention Type DRUG

PF-00489791

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

Intervention Type DRUG

PF-00489791

PF-00489791 4 mg, oral, tablets, once daily, for 28 days

Intervention Type DRUG

PF-00489791

PF-00489791 10 mg, oral, tablets, once daily, for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Type 1 or 2 diabetes on prescribed medications
2. Secondary, severe, or malignant hypertension
3. History of a significant cardiovascular event within the last 12 months of enrollment
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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National Research Institute

Los Angeles, California, United States

Site Status

Apex Research Institute

Santa Ana, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Andres Patron, DO, PA

Pembroke Pines, Florida, United States

Site Status

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, United States

Site Status

Twin Cities Clinical Research

Brooklyn Center, Minnesota, United States

Site Status

Riser Medical Associates

Picayune, Mississippi, United States

Site Status

Midwest Internists Clinical Research, P.C.

St Louis, Missouri, United States

Site Status

Triangle Medical Research Associates, LLC

Cary, North Carolina, United States

Site Status

Medical Research Associates of Charlotte, Inc

Charlotte, North Carolina, United States

Site Status

Triangle Medical Research Associates

Raleigh, North Carolina, United States

Site Status

Triangle Medical Research

Raleigh, North Carolina, United States

Site Status

Piedmont Medical Research Associates

Winston-Salem, North Carolina, United States

Site Status

Sterling Research Group limited

Cincinnati, Ohio, United States

Site Status

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

Site Status

Volunteer Research Group

Knoxville, Tennessee, United States

Site Status

Clinical Research Associates Incorporated

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A7331007

Identifier Type: -

Identifier Source: org_study_id

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