- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680654
Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID
December 14, 2015 updated by: Bayer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Germany, 69126
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Löwenstein, Baden-Württemberg, Germany, 74245
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Hessen
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Gießen, Hessen, Germany, 35392
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Mecklenburg-Vorpommern
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Greifswald, Mecklenburg-Vorpommern, Germany, 17475
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Sachsen
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Dresden, Sachsen, Germany, 01307
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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At baseline, throughout study days 1 and 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
August 1, 2009
Study Completion (ACTUAL)
November 1, 2009
Study Registration Dates
First Submitted
May 16, 2008
First Submitted That Met QC Criteria
May 19, 2008
First Posted (ESTIMATE)
May 20, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 16, 2015
Last Update Submitted That Met QC Criteria
December 14, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11917
- 2008-000914-65 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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