- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Chandigarh, Inde, 160012
- Recrutement
- Dr Preksha Dwivedi
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Contact:
- Preksha Dwivedi, MD
- Numéro de téléphone: +91-8109492343
- E-mail: drpreksha07@gmail.com
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Contact:
- Shefali Sharma, MD
- Numéro de téléphone: +91-9417372439
- E-mail: Sharmashefali@hotmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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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Comparateur placebo: 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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change in Pulmonary artery pressures
Délai: Baseline and 6 months
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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
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Baseline and 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
1.Change in 6 Minute walk distance
Délai: Baseline and 6 months
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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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Nandita Kakker, M.D, Institutional ethics committee,PGIMER Chandigarh,India
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies de la peau
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies du tissu conjonctif
- Hypertension pulmonaire
- Sclérose
- Hypertension
- Sclérodermie systémique
- Sclérodermie diffuse
- Hypertension artérielle pulmonaire
- Hypertension pulmonaire primitive familiale
- Mécanismes moléculaires de l'action pharmacologique
- Agents antihypertenseurs
- Agents vasodilatateurs
- Agents urologiques
- Inhibiteurs d'enzymes
- Inhibiteurs de la phosphodiestérase
- Inhibiteurs de la phosphodiestérase 5
- Antagonistes des récepteurs de l'endothéline
- Citrate de sildénafil
- Bosentane
Autres numéros d'identification d'étude
- MK/2927/DM/9430
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Sildenafil 20mg and Bosentan 62.5mg
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