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NVA237 BID Versus Placebo Twelve-week Efficacy Study

NCT01715298 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2015-03-11

Study results available
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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.

Conditions

Interventions

DRUG

NVA237

NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules

DRUG

Placebo

Placebo powder for inhalation in single-dose capsules (matching those for NVA237).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01715298 on ClinicalTrials.gov