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NCT01715298 · ClinicalTrials.gov registry record · Phase 3
NVA237 BID Versus Placebo Twelve-week Efficacy Study
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 432
- Enrollment target
NCT01715298: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01715298 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 432 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01715298, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 432 participants
- Enrollment target
Study Summary
The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.
Primary Outcome
The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is measured at week 12 of treatment. Serial lung function measurements are taken at the following time points following dosing at week 12 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Week 12 (defined as the mean
Interventions
- DRUG Placebo
- DRUG NVA237
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 3 |
What the finished NCT01715298 record still lists
NCT01715298 is an interventional study that assigns participants to a tested intervention. The registered 432 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01715298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01715298 about?
NCT01715298 is a clinical study titled "NVA237 BID Versus Placebo Twelve-week Efficacy Study". The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to a...
What is the current status of trial NCT01715298?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 432 participants. The study started on 2012-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01715298?
The interventions under investigation include: Placebo (DRUG), NVA237 (DRUG).
Who is sponsoring clinical trial NCT01715298?
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 NCT01715298's enrollment target sits among peer trials
432 876th of 2000 higher than 1,124 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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