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

NCT ID: NCT00680654

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension, Pulmonary

Keywords

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Pulmonary hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Riociguat (Adempas, BAY63-2521)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Heidelberg, Baden-Wurttemberg, Germany

Site Status

Löwenstein, Baden-Wurttemberg, Germany

Site Status

Giessen, Hesse, Germany

Site Status

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Dresden, Saxony, Germany

Site Status

Countries

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Germany

Related Links

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http://www.clinicaltrialsregister.eu/

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

Other Identifiers

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2008-000914-65

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11917

Identifier Type: -

Identifier Source: org_study_id