Status:
COMPLETED
An Open Multiple Dose Titration Study In Patients With Pulmonary Hypertension
Lead Sponsor:
Bayer
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a study to demonstrate the feasibility of an individual dose titration scheme based on the systolic blood pressure with a dose range from 1.0 mg TID to 2.5 mg TID. Patients suffering from chro...
Detailed Description
Specification of primary outcome measures for long-term safety and tolerability: Adverse events, blood pressure and heart rate, 12 lead ECG, clinical chemistry and hematology, Troponin I
Eligibility Criteria
Inclusion
- Patients with CTEPH or PAH in NYHA class II or III
Exclusion
- Patients with PDE 5 inhibitor or prostacycline pretreatment, relevant pulmonary diseases, relevant cardiac diseases, severe coagulation disorders, moderate to severe hepatic or renal insufficiency, pregnancy, hypotension
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00454558
Start Date
January 1 2007
End Date
September 1 2014
Last Update
October 16 2015
Active Locations (15)
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1
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
Löwenstein, Baden-Wurttemberg, Germany, 74245
3
München, Bavaria, Germany, 81377
4
Regensburg, Bavaria, Germany, 93042