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NCT01154127 · ClinicalTrials.gov registry record · Phase 3

Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
108
Enrollment target

NCT01154127: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT01154127 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 108 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01154127, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
108 participants
Enrollment target

Study Summary

The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.

Primary Outcome

SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.

Interventions

  • DRUG Placebo
  • DRUG NVA237

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2010-06
Est. Completion 2011-02
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01154127 record still lists

NCT01154127 is an interventional study that assigns participants to a tested intervention. The registered 108 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 (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01154127 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01154127 about?

NCT01154127 is a clinical study titled "Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)". The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.

What is the current status of trial NCT01154127?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2010-06. Estimated completion is 2011-02.

What interventions are being tested in trial NCT01154127?

The interventions under investigation include: Placebo (DRUG), NVA237 (DRUG).

Who is sponsoring clinical trial NCT01154127?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01154127's enrollment target sits among peer trials

108 1664th of 2000 higher than 335 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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Source: ClinicalTrials.gov NCT01154127, the US trial registry maintained by the National Library of Medicine. NCT01154127 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.