Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID - Tabular View

Tracking Information

First Received Date ^ICMJE

May 16, 2008

Last Updated Date

September 11, 2009

Start Date ^ICMJE

October 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Impact of a single dose of BAY 63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics. [ Time Frame: At baseline, throughout study days 1 and 2 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00680654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID

Official Title ^ICMJE

Interaction Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of Single Doses of 0.5 and 1 mg of BAY 63-2521 in Patients With PAH and Stable Treatment of Sildenafil 20 mg TID in a Non-randomized, Non-blinded Design

Brief Summary

This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY 63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Hypertension, Pulmonary

Intervention ^ICMJE

Drug: Riociguat (BAY63-2521)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with pulmonary hypertension stable for the last 6 weeks
Treated with Sildenafil 3 x 20 mg
Undergoing routine invasive diagnostics.

Exclusion Criteria:

Pre-existing lung disease other than pulmonary arterial hypertension,
Acute or severe chronic left heart failure,
Severe coronary artery disease,
Uncontrolled arterial hypertension;
Congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension,
Systolic blood pressure < 100 mmHg, heart rate < 55 bpm or >105 bpm, PaO2/FiO2 < 50 mmHg,
PaCO2 > 55 mmHg,
Severe hepatic insufficiency,
Severe renal insufficiency,
Administration of strong CYP3A4 inhibitors or inductors

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00680654

Responsible Party

Therapeutic Area Head, Bayer HealthCare AG

Study ID Numbers ^ICMJE

11917, 2008-000914-65

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP