Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03053739
Status:
UNKNOWN
Last Update Posted:
2017-02-15
First Post:
2016-12-29
Brief Title:
To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BosSilSS
Brief Summary:
The study will be carried out on 50 consecutive consenting patients of systemic sclerosis with PAH recruited from outpatient department of internal medicine and rheumatology clinic of PGIMER Chandigarh India It is a single centre double blind randomised controlled trial evaluating the effect of upfront dual therapy sildenafil and bosentan vs monotherapy sildenafil Participants will be randomised in 11 ratio to one of treatment arms Placebo and PDE-5 inhibitors 20 mg BD to 60 mg if patient tolerates the drug well to one study arm and PDE-5 inhibitors plus ER antagonist 625 to max of 125 to other study group
Detailed Description:
All patients fulfilling the SSc classification criteria of American College of Rheumatology during the study period will be screened for presence of PAH Diagnosed cases of PAH based on CD echo with PAP 35mmHg based on echocardiography will be enrolled in studyBaseline NYHA functional class and 6 min walk distance in meters will be assessed Heamogram and LFT will be measured Patients will be assessed at two weeks for side effectssafety issues 6MWT and NYHA functional class will be reassessed at 3 months and 6 months2D echo will be done at 6 months to measure mPAP RandomizationAll eligible patients will be randomized in a 11 ratio in blocks of ten between the two arms Randomization will be stratified based on severity of PAH The drugs will be labelled as A and B randomly by another staff member who will not be involved in deciding the treatment of the study subjects The randomization sequence will be generated using computer random number generator
Blinding will be ensured by matching placebo for ERA in one group and will labelled one treatment arm as A and other treatment arm as B Allocation concealment will be ensured by means of enclosing the randomization sequence in sealed opaque envelopes Sealed opaque envelopes will contain Code A or Code B
Intervention-The study consists of two treatment arms The study drugs mainly Bosentan and Placebo will be packed into matching tablets at the dosage 625 mg One treatment arm will contain Sildenafil and Placebo while other treatment arm will contain Sildenafil and Bosentan Treatment will be initiated as 20 mg twice a day for Sildena-fil in combination with placebo once a day in one treatment arm and with Bosentan 625 mg once a day in other treatment arm Dose of Sildenafil will be increased to 20 mg thrice a day at four weeks and that of Bosentan to 625 mg twice a day Placebo will be also be provided twice a dayThis will be continued till end of study period Dose adjustments in case of adverse events will be made depending on the severity of adverse events
Statistical analysis- Intention to treat analysis will be carried for the primary and secondary outcomes For continuous outcomes unpaired t-test and for dichotomous outcomes chi-squares test with Yates correction will be used P005 will be considered significant
Blinding will be ensured by matching placebo for ERA in one group and will labelled one treatment arm as A and other treatment arm as B Allocation concealment will be ensured by means of enclosing the randomization sequence in sealed opaque envelopes Sealed opaque envelopes will contain Code A or Code B
Intervention-The study consists of two treatment arms The study drugs mainly Bosentan and Placebo will be packed into matching tablets at the dosage 625 mg One treatment arm will contain Sildenafil and Placebo while other treatment arm will contain Sildenafil and Bosentan Treatment will be initiated as 20 mg twice a day for Sildena-fil in combination with placebo once a day in one treatment arm and with Bosentan 625 mg once a day in other treatment arm Dose of Sildenafil will be increased to 20 mg thrice a day at four weeks and that of Bosentan to 625 mg twice a day Placebo will be also be provided twice a dayThis will be continued till end of study period Dose adjustments in case of adverse events will be made depending on the severity of adverse events
Statistical analysis- Intention to treat analysis will be carried for the primary and secondary outcomes For continuous outcomes unpaired t-test and for dichotomous outcomes chi-squares test with Yates correction will be used P005 will be considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None