| CTRI Number |
CTRI/2017/12/010736 [Registered on: 04/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the effects and safety of 2 drugs in a disease of heart with increased pressures in lung |
|
Scientific Title of Study
|
A randomised placebo-controlled study to compare the safety and efficacy of sildenafil mono therapy with combination therapy of ambrisentan and sildenafil in pulmonary hypertension including eisenmenger syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajesh Vijayvergiya |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute Of Medical Education and Research |
| Address |
Department of cardiology
Post graduate institute of medical education and research
PGIMER
Chandigarh
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009513 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaadab Ahmed Mohammed |
| Designation |
Senior Resident |
| Affiliation |
Postgraduate Institute Of Medical Education and Research |
| Address |
Department of cardiology
Post graduate institute of medical education and research
PGIMER
Chandigarh
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8727084695 |
| Fax |
|
| Email |
shaadab27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Vijayvergiya |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute Of Medical Education and Research |
| Address |
Department of cardiology
Post graduate institute of medical education and research
PGIMER
Chandigarh
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009513 |
| Fax |
|
| Email |
rajeshvijay999@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical education and research
Institutional grant as part of thesis |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Sector 12 Chandigarh India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rajesh Vijayvergiya |
Postgraduate Institute of Medical education and research |
Department of Cardiology
AdvancedCardiac centre
Room no 1035
Level 1,C block
Sector 12
Chandigarh
Chandigarh
CHANDIGARH |
7087009513
rajeshvijay999@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee PGIMER chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Eisenmenger syndrome
Primary pulmonary hypertension , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug therapy |
To compare the efficacy and safety of sildenafil monotherapy versus combination therapy in eisenmenger syndrome and primary PAH |
| Comparator Agent |
Placebo versus ambrisentan |
To compare efficacy and safety of ambrisentan,an endothelial receptor antagonist to lower pulmonary pressures in eisenmenger and primary pulmonary hypertension
versus placebo. Double blind ,
randomised trial. Placebo one tablet od for 6 weeks. Ambrisentan 5 mg OD for 6weeks per oral |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary pulmonary hypertension and eisenmenger syndrome will be included
Without Comorbid hepatic or renal diseases |
|
| ExclusionCriteria |
| Details |
1.Secondary causes of pulmonary hypertension
2. Comorbid hepatic and renal conditions
3.Patients with coronary artery disease
4.Patients with contraindications to the drugs |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional class (NYHA)
6 min walk test |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Echocardiography changes in right heart function |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
14/08/2017 |
| 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
|
Years="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective randomised placebo controlled double blind study to assess the efficacy and safety of sildenafil and ambrisentan combination therapy versus mono therapy with sildenafil. 20 patients with primary pulmonary hypertension or eisenmenger syndrome will be included and randomised to receive either sildenafil with ambrisentan or sildenafil and placebo. They will be followed up for 6 weeks. Their baseline functional status and echocardiographic findings will be recorded and assessed at 6 week follow up. Any adverse effect will also be recorded and reported. This study has been given ethical clearance from the institute ethics committee PGIMER CHANDIGARH. This study is intended to be a part of postgraduate thesis.
|