Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID
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
2 other identifiers
interventional
7
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedDecember 16, 2015
December 1, 2015
10 months
May 16, 2008
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.
At baseline, throughout study days 1 and 2
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Patients with pulmonary hypertension stable for the last 6 weeks
- Treated with Sildenafil 3 × 20 mg
- Undergoing routine invasive diagnostics.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (5)
Unknown Facility
Heidelberg, Baden-Wurttemberg, 69126, Germany
Unknown Facility
Löwenstein, Baden-Wurttemberg, 74245, Germany
Unknown Facility
Giessen, Hesse, 35392, Germany
Unknown Facility
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
Unknown Facility
Dresden, Saxony, 01307, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 20, 2008
Study Start
October 1, 2008
Primary Completion
August 1, 2009
Study Completion
November 1, 2009
Last Updated
December 16, 2015
Record last verified: 2015-12