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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03053739 |
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Date of registration:
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29/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis
BosSilSS |
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Scientific title:
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Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03053739 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Preksha Dwivedi, MD |
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Address:
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Telephone:
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+91-8109492343 |
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Email:
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drpreksha07@gmail.com |
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Affiliation:
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Name:
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Preksha Dwivedi, M D |
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Address:
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Telephone:
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+91-8109492343 |
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Email:
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drpreksha07@gmail.com |
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Affiliation:
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Name:
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Nandita Kakker, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institutional ethics committee,PGIMER Chandigarh,India |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female patients aged 18 years
- Patients with systemic sclerosis
- PAH diagnosed as PAP>35mmHg
- NYHA functional class II,III,IV
- SSc disease duration >1years
Exclusion Criteria:
- Forced vital capacity <60% predicted
- Renal insufficiency
- Left heart disease and other relevant cardiac conditions
- Pregnant or breastfeeding female
- Patients on PAH specific therapy
- Liver disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Associated Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Sildenafil 20mg and Placebo
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Drug: Sildenafil 20mg and Bosentan 62.5mg
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Primary Outcome(s)
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Change in Pulmonary artery pressures
[Time Frame: Baseline and 6 months]
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Secondary Outcome(s)
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Emergent side effects of Sildenafil and Bosentan
[Time Frame: Baseline to 6 months]
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Time To Clinical Worsening (TTCW)
[Time Frame: Baseline and 6 months]
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1.Change in 6 Minute walk distance
[Time Frame: Baseline and 6 months]
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Secondary ID(s)
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MK/2927/DM/9430
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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