CTRI/2016/11/007424
Recruiting
Phase 4
Phase IV study to evaluate safety and efficacy of Pulmosil (Sildenafil Injection) for the treatment of pulmonary arterial hypertension in India.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Pulmonary Arterial Hypertension.
- Sponsor
- Sun Pharmaceutical Industries Limited
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following criteria to be considered for
- •enrollment in the study:
- •1\. Patients aged 18 to 65 years with confirmed diagnosis of Pulmonary arterial hypertension, who are on oral sildenafil and temporarily require (at least 3 days) intravenous sildenafil as per investigators discretion (eg. Clinical worsening).
- •2\.Patients or his/her legally acceptable representative willing to give their informed consent.
Exclusion Criteria
- •Subjects meeting any of the following criteria must be excluded from
- •enrollment in the study:
- •Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •2\. Patients with uncorrected congenital heart disease and PAH.
- •3\. Patients with pulmonary hypertension due to thromboembolism.
- •4\. Patients with pulmonary hypertension secondary to sickle cell disease.
- •Patients with HIV.
- •6\. Patients with chronic obstructive airway disease.
- •7\. Patients with congestive heart failure (NYH III and IV) or stroke, or life\-threatening arrhythmia.
- •8\. Patients with coronary artery disease causing unstable angina.
Outcomes
Primary Outcomes
Not specified
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