check_circleStudy 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
  • - Patients with pulmonary hypertension stable for the last 6 weeks
    - Treated with Sildenafil 3 × 20 mg
    - Undergoing routine invasive diagnostics.
  • - 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
7
Trial Dates
October 2008 - November 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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.
    date_rangeTime Frame:
    At baseline, throughout study days 1 and 2
    enhanced_encryption
    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
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe