- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03053739
To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis (BosSilSS)
Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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 study.Baseline 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 effects/safety issues. 6MWT and NYHA functional class will be reassessed at 3 months and 6 months.2D echo will be done at 6 months to measure mPAP RandomizationAll eligible patients will be randomized in a 1:1 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 62.5 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 62.5 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 62.5 mg twice a day. Placebo will be also be provided twice a day.This 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 Yate's correction will be used. P<0.05 will be considered significant
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Chandigarh, Indien, 160012
- Rekruttering
- Dr Preksha Dwivedi
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Kontakt:
- Preksha Dwivedi, MD
- Telefonnummer: +91-8109492343
- E-mail: drpreksha07@gmail.com
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Kontakt:
- Shefali Sharma, MD
- Telefonnummer: +91-9417372439
- E-mail: Sharmashefali@hotmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Combination arm A-Sildenafil and Bosentan
Combination Arm A -Intervention- Drug
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Sildenafil 20 mg three times a day and bosentan 62.5mg two times a day
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Placebo komparator: Monotherapy arm-Sildenafil and Placebo
Monotherapy arm B Intervention-Drugs Tab Sildenafil 20mg- three times a day for 6 months, and Placebo tab (matched for bosentan) for 6 months
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Sildenafil 20 mg three times a day and placebo (matched for bosentan)two times a day
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Pulmonary artery pressures
Tidsramme: Baseline and 6 months
|
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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
1.Change in 6 Minute walk distance
Tidsramme: Baseline and 6 months
|
1. To compare change in 6 MWD at baseline, and 6 months when treated with single versus dual therapy.
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Baseline and 6 months
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Time To Clinical Worsening (TTCW)
Tidsramme: Baseline and 6 months
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To compare time to clinical worsening (TTCW) in SSc patients when treated with single versus dual therapy.
TTCW is defined as first occurrence of all cause deaths, PAH related hospitalisation, worsening of symptoms defined as a decrease of >15% in 6 min walk distance and worsening of NYHA functional class.
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Baseline and 6 months
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Emergent side effects of Sildenafil and Bosentan
Tidsramme: Baseline to 6 months
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To compare the emergent side effects of sildenafil and bosentan by way of comparison of serious and nonserious side effects.
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Baseline to 6 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Nandita Kakker, M.D, Institutional ethics committee,PGIMER Chandigarh,India
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjerte-kar-sygdomme
- Karsygdomme
- Hudsygdomme
- Luftvejssygdomme
- Lungesygdomme
- Bindevævssygdomme
- Hypertension, lunge
- Sclerose
- Forhøjet blodtryk
- Sklerodermi, systemisk
- Sklerodermi, diffus
- Pulmonal arteriel hypertension
- Familiær primær pulmonal hypertension
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Vasodilatorer
- Urologiske midler
- Enzymhæmmere
- Fosfodiesterasehæmmere
- Fosfodiesterase 5-hæmmere
- Endotelinreceptorantagonister
- Sildenafil Citrat
- Bosentan
Andre undersøgelses-id-numre
- MK/2927/DM/9430
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Kliniske forsøg med Sildenafil 20mg and Bosentan 62.5mg
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ActelionAfsluttetPulmonal arteriel hypertensionForenede Stater
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University of Mississippi Medical CenterAfsluttetVaskulær funktion | RaceforskelForenede Stater
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Novartis PharmaceuticalsAfsluttetPulmonal arteriel hypertensionTyskland, Belgien, Forenede Stater, Litauen, Det Forenede Kongerige, Italien, Australien