CTRI

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CTRI Number

CTRI/2011/09/001992 [Registered on: 07/09/2011] Trial Registered Retrospectively

Last Modified On:

07/09/2011

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Comparison Of Efficacy Of Different Treatment Regimens In Pulmonary Artery Hypertension Secondary To Lung Disease And/Or Hypoxia

Scientific Title of Study

comparison of efficacy Of different treatment regimens In pulmonary artery hypertension secondary to lung disease and/or hypoxia.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sajal ajmani
Designation	JR medicine
Affiliation	AIIMS
Address	Department of medicine ALL INDIA INSTITUTE OF MEDICAL SCIENCES New Delhi South DELHI 110608 India
Phone	9873570408
Fax
Email	mrabhilekh@gmail.com

Details of Contact Person
Scientific Query

Name	Dr S K Sharma
Designation	HOD Medicine
Affiliation	AIIMS
Address	Medicine office 3rd floor teaching block ALL INDIA INSTITUTE OF MEDICAL SCIENCES South DELHI 110608 India
Phone	01126594415
Fax
Email	sksharma@aiims.ac.in

Details of Contact Person
Public Query

Name	Dr S K Sharma
Designation	HOD Medicine
Affiliation	AIIMS
Address	Medicine office 3rd floor teaching block ALL INDIA INSTITUTE OF MEDICAL SCIENCES South DELHI 110608 India
Phone	01126594415
Fax
Email	sksharma@aiims.ac.in

Source of Monetary or Material Support

AIIMS hospital

Primary Sponsor

Name	Dr SK Sharma
Address	Professor and Head Department of Medicine All India Institute of Medical Sciences New Delhi 110608 Phone: 011-2659-4415/3303
Type of Sponsor	Other [Dr S K Sharma]

Details of Secondary Sponsor

Name	Address
Dr ANANT MOHAN Assoc Prof Deptt of Medicine AIIMS	AIIMS, New delhi
Dr GC KHILNANI Prof Deptt of Medicine AIIMS	AIIMS New Delhi
Dr SANDEEP SINGH Asstt Prof Deptt of Cardiology AIIMS	AIIMS, New delhi
Dr SANJEEV SINHA Assoc Prof Deptt of Medicine AIIMS	AIIMS, New Delhi
Dr V SREENIVAS Assoc Prof Deptt of Biostatistics AIIMS	AIIMS, New Delhi

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sajal Ajmani	AIIMS hospital	Medicine ward C2 and D2, 2nd floor ward block ALL INDIA INSTITUTE OF MEDICAL SCIENCES South DELHI	9873570408 sajalajmani@gmail.com
Dr Sajal Ajmani	Medicine OPD all rooms	ALL INDIA INSTITUTE OF MEDICAL SCIENCES South DELHI	9873570408 sajalajmani@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIMS	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	Pulmonary artery hypertension secondary to lung disease and/or hypoxia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Bosentan and sildenafil	Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. No fixed dose combination will be used.
Comparator Agent	Sequential therapy	Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started be added after 3 months. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. Bosentan and sildenafil will be in combination in the last 3 months. No fixed dose combination will be used.
Comparator Agent	Sildenfil	Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	• Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmHg (done in department of cardiology, AIIMS) • Age more than 18 years • Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease • Willing to consent to participate in the trial • WHO functional class I,II, III

ExclusionCriteria

Details

• WHO functional class IV
• Patient participating in any other trial
• Concomitant coronary artery disease
• Nitrate intake
• Liver dysfunction
• Pregnancy and lactation

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Following parameters at 6 months • WHO functional classification • 6 minute walk test • Pulmonary function test • Visual analog scale for dyspnea • Echocardiography measuring pulmonary artery pressure	Following parameters at 6 months • WHO functional classification • 6 minute walk test • Pulmonary function test • Visual analog scale for dyspnea • Echocardiography measuring pulmonary artery pressure

Secondary Outcome

Outcome	TimePoints
Following parameters at 3 months • WHO functional classification • 6 minute walk test • Pulmonary function test • Visual analog scale for dyspnea • Echocardiography measuring pulmonary artery pressure • Biochemical markers and at 6 months	3 months

Target Sample Size

Total Sample Size="45"
Sample Size from India="45"
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 3/ Phase 4

Date of First Enrollment (India)

01/09/2011

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia. It involves 3 arms, one getting monotherapy with sildenafil for 6 months, 2^nd getting bosentan monotherapy initially for 3 months and then combination of sildenafil and bosentan for 3 months, 3^rd getting combination sildenafil and bosentan from the beginning for 6 months. The aim is to decide when is the best time to start combination therapy either from start or at the time of drug failure. Improvement will be assessed by change in functional class, pulmonary pressures measured by ECHO, pulmonary function test, six minute walk test and biochemical markers. Lack of randomized trials and Indian data is there on the subject. Also adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately.