NCT00635232

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

A Randomized, Double-Blind, Placebo And Active-Controlled, Parallel Group Study To Evaluate The Dose-Related Efficacy And Safety Of PS433540 In Subjects With Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Ligand Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2008-03-13
• Last updated: 2011-09-16
• Results posted: 2011-09-13

Locations

40 sites across 1 country: United States