Status:

COMPLETED

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.

Lead Sponsor:

Bayer

Conditions:

Pulmonary Hypertension

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

Brief Summary

The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Detailed Description

Adverse event data will be covered in Adverse events section.

Eligibility Criteria

Inclusion

  • Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.

Exclusion

  • All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.

Key Trial Info

Start Date :

February 23 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 27 2012

Estimated Enrollment :

262 Patients enrolled

Trial Details

Trial ID

NCT00855465

Start Date

February 23 2009

End Date

June 27 2012

Last Update

November 21 2023

Active Locations (89)

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Page 1 of 23 (89 locations)

1

La Jolla, California, United States, 92093

2

Sacramento, California, United States, 95817

3

Miami, Florida, United States, 33136

4

Iowa City, Iowa, United States, 52242

A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. | DecenTrialz