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NCT00970268 · ClinicalTrials.gov registry record · Phase 3
Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 291
- Enrollment target
NCT00970268: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00970268 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 291 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00970268, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 291 participants
- Enrollment target
Study Summary
The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.
Primary Outcome
Change From Baseline (Visit 2 of lead-in Study NCT00891462, \[LAS-MD-33\]) to Week 52 (Week 64 From Start of NCT00891462, \[LAS-MD-33\]) in Morning Predose (Trough) FEV1
Interventions
- DRUG Aclidinium bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00970268 record still lists
NCT00970268 is an interventional study that assigns participants to a tested intervention. The registered 291 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 (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Aclidinium bromide is the first listed.
NCT00970268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00970268 about?
NCT00970268 is a clinical study titled "Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)". The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treat...
What is the current status of trial NCT00970268?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2009-08. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00970268?
The interventions under investigation include: Aclidinium bromide (DRUG).
Who is sponsoring clinical trial NCT00970268?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00970268's enrollment target sits among peer trials
291 1168th of 2000 higher than 830 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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