Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
NCT01449253 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2013-01-29
Summary
This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.This is to find out when to start combination therapy (sildenafil plus bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.
Conditions
- Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
Interventions
- DRUG
-
Sildenafil
20 mg initially and then increased to 20 mg TDS if there is no fall in BP
- DRUG
-
Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD
Sponsors & Collaborators
-
All India Institute of Medical Sciences
lead OTHER
Principal Investigators
-
Surendra K. Sharma, MD,Ph.D · All India Institute of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2013-07-31
- Completion
- 2013-07-31
Countries
- India
Study Locations
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