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NCT01709864 · ClinicalTrials.gov registry record · Phase 3
NVA237 Versus Placebo 12-week Efficacy Study
A Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
- 20
- Study locations
NCT01709864: Completed Phase 3 study of Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals.
NCT01709864 is a Phase 3 study of Chronic Obstructive Pulmonary Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 440 participants, below the 1,749-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01709864, a Phase 3 study of Chronic Obstructive Pulmonary Disease, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
- 20
- Study locations
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) at week 12 of treatment. Serial lung function measurements are taken at various time points following dosing at week 12 to calculate the AUC.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NVA237
Study Locations (20)
Florida
- Novartis Investigative Site - Brandon
- Novartis Investigative Site - Clearwater
- Novartis Investigative Site - DeFuniak Springs
- Novartis Investigative Site - Edgewater
- Novartis Investigative Site - Fort Lauderdale
- Novartis Investigative Site - Hialeah
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Miami
- Novartis Investigative Site - Miami
California
- Novartis Investigative Site - Fountain Valley
- Novartis Investigative Site - Fullerton
- Novartis Investigative Site - Los Angeles
- Novartis Investigative Site - Los Angeles
- Novartis Investigative Site - Riverside
- Novartis Investigative Site - San Diego
- Novartis Investigative Site - San Diego
Alabama
- Novartis Investigative Site - Homewood
- Novartis Investigative Site - Jasper
Arizona
- Novartis Investigative Site - *See Various Dept.'s*
- Novartis Investigative Site - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01709864 record still lists
NCT01709864 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, below the 1,749-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01709864 names 20 study sites across 4 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01709864 about?
NCT01709864 is a clinical study titled "NVA237 Versus Placebo 12-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 ...
What is the current status of trial NCT01709864?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2012-11. Estimated completion is 2013-10.
What conditions does trial NCT01709864 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT01709864?
The interventions under investigation include: Placebo (DRUG), NVA237 (DRUG).
Who is sponsoring clinical trial NCT01709864?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01709864 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01709864's enrollment target sits among peer trials
440 26th of 86 higher than 61 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease 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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