A clinical trial to study the safety and efficacy of Pulmosil (Sildenafil Injection) for the treatment of hypertension.

Phase 4

Recruiting

• Conditions: Pulmonary Arterial Hypertension.

• Registration Number: CTRI/2016/11/007424
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

This is multi-centric, open label, single arm study , phase IV study, planned in different centres in 25 patients in India. Patients who are on oral sildenafil will be hospitalized and temporarily given Sildenafil Injection as per actual clinical practice (as per investigator’ discretion). 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). Efficacy parameters will be evaluated on baseline visit, treatment completion visit and study completion visit. The objective of evaluating safety and efficacy data on three visits is to obtain situational and conclusive clinical data (switching from oral to Sildenafil IV and vice versa) from

patients with PAH.

 **Primary Outcome measure(s): (Safety)**

·         Proportion of subjects with adverse events and serious adverse events during Sildenafil Injection treatment period.

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).

 **Secondary Outcome measure(s): (Efficacy)**

·         Mean change in distance travel in 6 min walk from baseline [ Time frame: Treatment completion, study completion]

·         Mean change in PAP from baseline [Time frame: Treatment completion, study completion].

Mean change in BNP level from baseline [ Time frame: Treatment completion, study completion].

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 25

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.
• Patients with uncorrected congenital heart disease and PAH.
• Patients with pulmonary hypertension due to thromboembolism.
• Patients with pulmonary hypertension secondary to sickle cell disease.
• Patients with HIV.
• Patients with chronic obstructive airway disease.
• Patients with congestive heart failure (NYH III and IV) or stroke, or life-threatening arrhythmia.
• Patients with coronary artery disease causing unstable angina.
• Patients with hypertension (BP >170/110).
• 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.
• Patients with resting hypotension [ BP < 90/50] or fluid depletion or severe left ventricular outflow obstruction, or autonomic dysfunction or veno-occlusive disease.
• Patients with bleeding disorders or active peptic ulcer.
• Patients who are using Alpha-adrenergic blocking agents.
• 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)	Treatment completion, study completion
•Proportion of subjects with adverse events and serious adverse events during Sildenafil Inj.treatment period.	Treatment completion, study completion
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).	Treatment completion, study completion

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome measure(s): (Efficacy)	•Mean change in distance travel in 6 min walk from baseline [ Time frame: Treatment completion, study completion]

Trial Locations

Locations (5)

All India Institute of Medical Sciences,; 🇮🇳 Delhi, DELHI, India

B M Birla Heart Research Centre; 🇮🇳 Kolkata, WEST BENGAL, India

CARE Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Chopda Medicare & Research Centre Pvt. Ltd.,Magnum Heart Institute; 🇮🇳 Nashik, MAHARASHTRA, India

Gandhi Medical College and Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

All India Institute of Medical Sciences,

🇮🇳Delhi, DELHI, India

Dr S Ramakrishnan

Principal investigator

9818186179

ramaaiims@gmail.com