Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680654
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : December 16, 2015
Information provided by (Responsible Party):

Brief Summary:
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: Riociguat (Adempas, BAY63-2521) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

Arm Intervention/treatment
Experimental: Arm 1 Drug: Riociguat (Adempas, 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.

Primary Outcome Measures :
  1. Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics. [ Time Frame: At baseline, throughout study days 1 and 2 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with pulmonary hypertension stable for the last 6 weeks
  • Treated with Sildenafil 3 × 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680654

Layout table for location information
Heidelberg, Baden-Württemberg, Germany, 69126
Löwenstein, Baden-Württemberg, Germany, 74245
Gießen, Hessen, Germany, 35392
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Dresden, Sachsen, Germany, 01307
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Additional Information:
Layout table for additonal information
Responsible Party: Bayer Identifier: NCT00680654    
Other Study ID Numbers: 11917
2008-000914-65 ( EudraCT Number )
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Keywords provided by Bayer:
Pulmonary hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Enzyme Activators
Molecular Mechanisms of Pharmacological Action