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A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension

NCT00635232 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2011-09-16

Study results available
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Summary

The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients will be entered into the treatment phase of the study and be given PS433540.

Conditions

Interventions

DRUG

irbesartan

300 mg (2 x 150 mg capsules) once daily for 12 weeks

DRUG

placebo

placebo capsules once daily for 12 weeks

DRUG

PS433540

200 mg (2 x 100 mg capsules) once daily for 12 weeks

DRUG

PS433540

400 mg (4 x 100 mg capsules) once daily for 12 weeks

DRUG

PS433540

800 mg (8 x 100 mg capsules) once daily for 12 weeks

Sponsors & Collaborators

  • Ligand Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Rene Belder, MD · Ligand Pharmaceuticals

  • Joel Neutel, MD · Orange County Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-11-30
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00635232 on ClinicalTrials.gov