EUCTR2020-002341-42-IT
Active, not recruiting
Phase 1
A 24-week, multicenter, randomized, double-blind, parallel-arm, placebocontrolled extension study to assess the safety of CSJ117, when added to existing standard of care asthma therapy in patients =18 years of age who completed study CCSJ117A12201C - CCSJ117A12201E1
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- OVARTIS PHARMA AG
- Enrollment
- 136
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •\- All participants must have been treated with a fixed dose combination of fluticasone propionate/salmeterol in one of two doses in stable dose alone or with additional controllers at label approved dosage (allowed only: LTRA, LAMA, Theophylline or its derivatives).
- •\- Participants completing the Treatment period and Follow\-up period of study CSJ117A12201C and continuing with study CCSJ117A12201E1 must have completed the Treatment period of CSJ117A12201C (i.e. did not discontinue blinded study treatment prematurely) and Follow\-up period of study CSJ117A12201C
- •\- Other protocol\-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 335
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 40
Exclusion Criteria
- •\- Participants who were enrolled into prior study CSJ117A12201C and developed a significant and/or permanent health condition during the prior study.
- •\- Participants who experienced a serious and drug\-related AE in the prior study CSJ117A12201C.
- •\- Participants receiving any prohibited medications.
- •\- Participants with a history or current diagnosis of ECG abnormalities.
- •\- Pregnant or nursing (lactating) women.
- •\- Other protocol\-defined exclusion criteria may apply
Investigators
Similar Trials
Active, not recruiting
Phase 1
Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2020-002341-42-BGovartis Pharma AG375
Active, not recruiting
Phase 1
Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2020-002341-42-SKovartis Pharma AG375
Active, not recruiting
Phase 1
Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthmaEUCTR2020-002341-42-DEovartis Pharma AG375
Active, not recruiting
Phase 1
Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2020-002341-42-PLovartis Pharma AG375
Active, not recruiting
Phase 1
Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2020-002341-42-LVovartis Pharma AG375