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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00680654
First received: May 16, 2008
Last updated: January 28, 2014
Last verified: January 2014

May 16, 2008
January 28, 2014
October 2008
August 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00680654 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension, Pulmonary
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.
Experimental: Arm 1
Intervention: Drug: Riociguat (BAY63-2521)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00680654
11917, 2008-000914-65
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

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