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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00680654

Purpose

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.

Condition	Intervention	Phase
Hypertension, Pulmonary	Drug: Riociguat (BAY63-2521)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Enrollment:	10
Study Start Date:	October 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Riociguat (BAY63-2521) The investigational drug will be given twice per subject, as single dose administration of BAY 63-2521 (0.5 mg and 1.0 mg) during the hemodynamic investigation.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680654

Locations

Germany, Baden-Württemberg

Heidelberg, Baden-Württemberg, Germany, 69126

Löwenstein, Baden-Württemberg, Germany, 74245
Germany, Hessen

Gießen, Hessen, Germany, 35392
Germany, Mecklenburg-Vorpommern

Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Germany, Sachsen

Dresden, Sachsen, Germany, 01307

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11917, 2008-000914-65
Study First Received:	May 16, 2008
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00680654 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Pulmonary hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions

Phosphodiesterase Inhibitors
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on March 18, 2010