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NCT00510510 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 281
- Enrollment target
- 20
- Study locations
NCT00510510: Completed Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis.
NCT00510510 is a Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD) that has completed, run by Novartis. The registered enrollment target is 281 participants, below the 643-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00510510, a Phase 2 study of Chronic Obstructive Pulmonary Disease (COPD), has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 281 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).
Primary Outcome
The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NVA237 100 µg
- DRUG NVA237 200 µg
Study Locations (20)
Other
- Novartis investigative site - Rueil-Malmaison
- Novartis investigative site - Nuremberg
- Novartis investigative site - Arnhem
- Novartis investigative site - Barcelona
Florida
- Novartis investigative site - Miami
- Novartis investigative site - Miami
- Novartis investigative site - Tamarac
Arizona
- Novartis investigative site - Glendale
- Novartis investigative site - Phoenix
South Carolina
- Novartis investigative site - Spartanburg
- Novartis investigative site - Union
Texas
- Novartis investigative site - Fort Worth
- Novartis investigative site - Houston
Colorado
- Novartis investigative site - Wheat Ridge
Delaware
- Novartis investigative site - Newark
Illinois
- Novartis investigative site - River Forest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2007-08 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
What the finished NCT00510510 record still lists
NCT00510510 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 643-participant average among 36 other Chronic Obstructive Pulmonary Disease (COPD) trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease (COPD) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00510510 names 20 study sites across 12 states, led by Other, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00510510 about?
NCT00510510 is a clinical study titled "Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease". This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).
What is the current status of trial NCT00510510?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 281 participants. The study started on 2007-08. Estimated completion is 2008-01.
What conditions does trial NCT00510510 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease (COPD).
What interventions are being tested in trial NCT00510510?
The interventions under investigation include: Placebo (DRUG), NVA237 100 µg (DRUG), NVA237 200 µg (DRUG).
Who is sponsoring clinical trial NCT00510510?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00510510 being conducted?
This trial has 20 study locations across Arizona, Colorado, Delaware, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease (COPD)
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 NCT00510510's enrollment target sits among peer trials
281 22nd of 36 higher than 15 of 36 other Chronic Obstructive Pulmonary Disease (COPD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease (COPD) 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.
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