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

December 14, 2015 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
      • Löwenstein, Baden-Württemberg, Germany, 74245
    • Hessen
      • Gießen, Hessen, Germany, 35392
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    • Sachsen
      • Dresden, Sachsen, Germany, 01307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At baseline, throughout study days 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (ESTIMATE)

May 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2015

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11917
  • 2008-000914-65 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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