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

Primary Purpose

Hypertension, Pulmonary

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Riociguat (Adempas, BAY63-2521)

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Pulmonary hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.

Secondary Outcome Measures

Full Information

NCT ID

NCT00680654

First Posted

May 16, 2008

Last Updated

December 14, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00680654

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Pulmonary

Keywords

Pulmonary hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Riociguat (Adempas, BAY63-2521)

Intervention Description

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69126

Country

Germany

City

Löwenstein

State/Province

Baden-Württemberg

ZIP/Postal Code

74245

Country

Germany

City

Gießen

State/Province

Hessen

ZIP/Postal Code

35392

Country

Germany

City

Greifswald

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

17475

Country

Germany

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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

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