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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: PF-00489791; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422461

A7331007

Details and patient eligibility

About

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

Enrollment: 135 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

135 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

PF-00489791 20 mg titrated to 40 mg

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

PF-00489791 4 mg

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

PF-00489791 10 mg

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791