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

Hypertension, Pulmonary Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680654
• Other study ID #: 11917
• Secondary ID: 2008-000914-65
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2008
• Last updated: December 14, 2015
• Start date: October 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.		At baseline, throughout study days 1 and 2	Yes

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