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NCT00855465 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
A Phase 3 study of Pulmonary Hypertension, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
- 20
- Study locations
NCT00855465: Completed Phase 3 study of Pulmonary Hypertension, sponsored by Bayer.
NCT00855465 is a Phase 3 study of Pulmonary Hypertension that has completed, run by Bayer. The registered enrollment target is 262 participants, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00855465, a Phase 3 study of Pulmonary Hypertension, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Riociguat (Adempas, BAY63-2521)
Study Locations (20)
Other
- - Corrientes
- - Innsbruck
- - Vienna
- - Bruxelles - Brussel
- - Leuven
- - Rio de Janeiro
California
- - La Jolla
- - Sacramento
Ohio
- - Cleveland
- - Columbus
Florida
- - Miami
Iowa
- - Iowa City
Maryland
- - Baltimore
Massachusetts
- - Boston
Texas
- - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2009-02-23 |
| Est. Completion | 2012-06-27 |
| Phase | Phase 3 |
What the finished NCT00855465 record still lists
NCT00855465 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00855465 names 20 study sites across 13 states, led by Other, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT00855465 about?
NCT00855465 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.". 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).
What is the current status of trial NCT00855465?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2009-02-23. Estimated completion is 2012-06-27.
What conditions does trial NCT00855465 study?
This clinical trial studies the following conditions: Pulmonary Hypertension.
What interventions are being tested in trial NCT00855465?
The interventions under investigation include: Placebo (DRUG), Riociguat (Adempas, BAY63-2521) (DRUG).
Who is sponsoring clinical trial NCT00855465?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00855465 being conducted?
This trial has 20 study locations across California, Florida, Iowa, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00855465's enrollment target sits among peer trials
262 18th of 72 higher than 55 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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