Study Completed

Hypertension, Pulmonary

Bayer Identifier:

11917

ClinicalTrials.gov Identifier:

NCT00680654

EudraCT Number:

2008-000914-65

EU CT Number:

Not Available

Interaction study in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg TID

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 80 Years

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

Trial summary

Enrollment Goal

Trial Dates

October 2008 - November 2009

Phase

Phase 1

Could I Receive a placebo

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Gießen, 35392, Germany
Completed		Löwenstein, 74245, Germany
Terminated		Greifswald, 17475, Germany
Terminated		Heidelberg, 69126, Germany
Completed		Dresden, 01307, Germany

Primary Outcome

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
Safety Issue:
yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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