To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis

NCT03053739 | Unknown Phase 4 DMC

• 1 other identifier: MK/2927/DM/9430
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 1:1 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 62.5 to max of 125 to other study group

Conditions

Associated Pulmonary Arterial Hypertension

Keywords

Systemic sclerosis, Associated Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Pulmonary artery pressures

  Change in Pulmonary artery pressures measured by echocardiography at baseline and 6 months in patients of systemic sclerosis with PAH when treatment with Single(PDE-5inhibitors at dose of 20 mg maximum upto 60mg) versus Dual therapy(PDE-5inhibitors and ER antagonist 62.5 mg maximum upto 125mg) for 6 months

  Baseline and 6 months

Secondary Outcomes (3)

• 1.Change in 6 Minute walk distance

  Baseline and 6 months

• Time To Clinical Worsening (TTCW)

  Baseline and 6 months

• Emergent side effects of Sildenafil and Bosentan

  Baseline to 6 months

Study Arms (2)

Combination arm A-Sildenafil and Bosentan

ACTIVE COMPARATOR

Combination Arm A -Intervention- Drug * Tab Sildenafil 20 mg - three times a day for 6 months,and * Tab Bosentan 62.5mg - twice a day for 6 months

Drug: Sildenafil 20mg and Bosentan 62.5mg

Monotherapy arm-Sildenafil and Placebo

PLACEBO COMPARATOR

Monotherapy arm B Intervention-Drugs Tab Sildenafil 20mg- three times a day for 6 months, and Placebo tab (matched for bosentan) for 6 months

Drug: Sildenafil 20mg and Placebo

Interventions

Sildenafil 20mg and Bosentan 62.5mg DRUG

Sildenafil 20 mg three times a day and bosentan 62.5mg two times a day

Combination arm A-Sildenafil and Bosentan

Sildenafil 20mg and Placebo DRUG

Sildenafil 20 mg three times a day and placebo (matched for bosentan)two times a day

Monotherapy arm-Sildenafil and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dr Preksha Dwivedi

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Sildenafil Citrate; Bosentan

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzenesulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrimidines

Study Officials

• Nandita Kakker, M.D

  Institutional ethics committee,PGIMER Chandigarh,India

  STUDY CHAIR

Central Study Contacts

Preksha Dwivedi, M D

CONTACT

+91-8109492343; drpreksha07@gmail.com

Shefali Sharma, M.D

CONTACT

+91-9417372439; sharmashefali@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SENIOR RESIDENT,CLINICAL IMMUNOLOGY AND RHEUMATOLOGY ,DEPT OF INTERNAL MEDICINE

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: February 15, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 15, 2017

Record last verified: 2017-02

Locations

IN (1)