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NCT01437735 · ClinicalTrials.gov registry record · Phase 2
Dose Finding Study for QAW039 in Asthma
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,043
- Enrollment target
NCT01437735: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01437735 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,043 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (684% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01437735, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,043 participants
- Enrollment target
Study Summary
This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.
Primary Outcome
Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.
Interventions
- DRUG Placebo
- DRUG Montelukast
- DRUG QAW039
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,043 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01437735 record still lists
NCT01437735 is an interventional study that assigns participants to a tested intervention. Its 1,043 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (684% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01437735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01437735 about?
NCT01437735 is a clinical study titled "Dose Finding Study for QAW039 in Asthma". This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This...
What is the current status of trial NCT01437735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,043 participants. The study started on 2011-08. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01437735?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG), QAW039 (DRUG).
Who is sponsoring clinical trial NCT01437735?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01437735's enrollment target sits among peer trials
1,043 25th of 2000 higher than 1,976 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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