A clinical trial to study the safety and efficacy of Pulmosil (Sildenafil Injection) for the treatment of hypertension.
- Conditions
- Health Condition 1: null- Pulmonary Arterial Hypertension.
- Registration Number
- CTRI/2016/11/007424
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
9. Patients with hypertension (BP >170/110).
10. Patients with schistosomiasis.
Patients with significant (i.e., >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days.
12. Patients with resting hypotension [ BP < 90/50] or fluid depletion or severe left ventricular outflow obstruction, or autonomic dysfunction or veno-occlusive disease.
13. Patients with bleeding disorders or active peptic ulcer.
14. Patients who are using Alpha-adrenergic blocking agents.
15. Patients who are taking nitrates in any form, either regularly or intermittently.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome measure(s): (Safety) <br/ ><br>â?¢Proportion of subjects with adverse events and serious adverse events during Sildenafil Inj.treatment period. <br/ ><br>Adverse events including medically significant laboratory changes-incidence, severity, causality and outcome will be collected from the signing of informed consent form until discontinuation of study treatment due to disease progression, intolerability, withdrawal of consent, death or treatment completion (switching back to oral sildenafil).Timepoint: Treatment completion, study completion
- Secondary Outcome Measures
Name Time Method Secondary Outcome measure(s): (Efficacy) <br/ ><br>â?¢Mean change in distance travel in 6 min walk from baseline [ Time frame: Treatment completion, study completion] <br/ ><br>â?¢Mean change in PAP from baseline [Time frame: Treatment completion, study completion]. <br/ ><br>â?¢Mean change in BNP level from baseline [ Time frame: Treatment completion, study completion]. <br/ ><br>Timepoint: Treatment completion, study completion