| CTRI Number |
CTRI/2016/11/007424 [Registered on: 03/11/2016] Trial Registered Prospectively |
| Last Modified On: |
17/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the safety and efficacy of Pulmosil
(Sildenafil Injection) for the treatment of hypertension.
|
|
Scientific Title of Study
|
Phase IV study to evaluate safety and efficacy of Pulmosil (Sildenafil Injection) for the treatment of pulmonary arterial hypertension in India. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ICR/15/020 Version No.2.1, dated 16/May/2017 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Nomita Chatterjee Bhandari |
| Designation |
General Manager |
| Affiliation |
Sun Pharma Laboratories Limited (SPLL) |
| Address |
Sun Pharma Laboratories Limited (SPLL)
‘Sun House’
201, B/1, Western Express Highway, Goregaon(E),
Mumbai-400063,
Maharashtra, India.
Sun Pharma Laboratories Limited (SPLL)
‘Sun House’
201, B/1, Western Express Highway, Goregaon(E),
Mumbai-400063,
Maharashtra, India.
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243246391 |
| Fax |
02228947101 |
| Email |
nomita.bhandari@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maulik Doshi |
| Designation |
Medical Monitor |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Sun Pharma laboratories Limited
Tandalja, Vadodara-390020
Gujarat
Sun Pharma laboratories Limited
Tandalja, Vadodara-390020
Gujarat
Vadodara
GUJARAT
390020
India |
| Phone |
02656615500 |
| Fax |
02652354897 |
| Email |
maulik.doshi@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Guruprasad Palekar |
| Designation |
Senior Manager |
| Affiliation |
Sun Pharma Laboratories Limited (SPLL) |
| Address |
Sun Pharma Laboratories Limited
Sun House,
201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063
Sun Pharma Laboratories Limited
Sun House,
201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243246215 |
| Fax |
02228947101 |
| Email |
guruprasad.palekar@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Limited
Sun House,
201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063
|
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Limited |
| Address |
Sun House,
201 B/1, Western Express Highway,
Goregaon ( E),Mumbai 400 063
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Ramakrishnan |
All India Institute of Medical Sciences, |
Department of Cardiology, All India Institute of Medical Sciences, New Delhi 110029
New Delhi
DELHI |
9818186179
ramaaiims@gmail.com |
| Das Dr Asit |
B M Birla Heart Research Centre |
B M Birla Heart Research Centre, 1/1, National Library Avenue, Kolkata-700027. West Bengal, India
Kolkata
WEST BENGAL |
9433138144
dradascard@rediffmail.com |
| Dr Soma Raju Bhupathiraju |
CARE Hospital |
CARE Hospital, Road No 1, Banjara Hills, Hyderabad-50034, Telangana, India
Hyderabad
ANDHRA PRADESH |
984960345
drbsomaraju@carehospitals.com |
| Dr Manojkumar Bhavarilal Chopada |
Chopda Medicare & Research Centre Pvt. Ltd.,Magnum Heart Institute |
3/5 Patil Lane No.1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik-422005
Nashik
MAHARASHTRA |
02532316200
rush_manoj@yahoo.com |
| Dr Nitin K Kabra |
Gandhi Medical College and Hospital |
Department of Cardiology, Gandhi Medical College and Hospital, Secunderabad, Telangana-500003
Hyderabad
ANDHRA PRADESH |
9848021417
nitink99@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| AIIMS-Institute’s ethics committee |
Submittted/Under Review |
| B. M. Birla Heart Research Centre Institutional Ethics Committee |
Submittted/Under Review |
| Gandhi Medical College Ethics committee |
Submittted/Under Review |
| Institutional Ethics Committee CARE Hospital |
Approved |
| Magna-Care Ethics Committee,Magna Care Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pulmonary Arterial Hypertension., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sildenafil Injection (10 mg/12.5 ml) |
Dosage and administration: The recommended dose is 10 mg/12.5 mL administered as an intravenous bolus injection three times a day.
Duration of administration: Sildenafil injection 10 mg/12.5 ml will be administered as per actual clinical practice (as per investigator’ discretion).
Sildefanfil orally will be giving after stopping injection as per investigator’ discretion.
The patient will receive one dose of 20 mg before study completion. The investigator would decide the best treatment post study completion.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome measure(s): (Safety)
•Proportion of subjects with adverse events and serious adverse events during Sildenafil Inj.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). |
Treatment completion, study completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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].
|
Treatment completion, study completion |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/12/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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]. |