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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 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.

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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).

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

FieldValue
Enrollment Target 262 participants
Start Date 2009-02-23
Est. Completion 2012-06-27
Phase Phase 3

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT00855465

The ClinicalTrials.gov registry entry for NCT00855465 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 262 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (57% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.