CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 261 enrolled
Drug / intervention
irbesartan +4 moredrug
Likely dose
irbesartan 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00635232
NCT00635232Phase 2Completed

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

Ligand Pharmaceuticals·interventional·Posted Mar 13, 2008·Updated Sep 16, 2011

In Brief

A Phase 2 clinical trial evaluating irbesartan, placebo, and 1 other intervention for Hypertension. Completed, enrolled 261 participants across 40 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2008
Enrollment StartMar 1, 2008
Primary CompletionNov 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.3 years ago

Interventions

irbesartandrug

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

placebodrug

placebo capsules once daily for 12 weeks

PS433540drug

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

PS433540drug

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

PS433540drug

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