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A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

NCT01005901 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1324

Last updated 2012-04-12

Study results available
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Summary

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

DRUG

Glycopyrronium bromide

Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI)

DRUG

Placebo

Placebo inhalation capsules were provided for use via a SDDPI

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States
  • Australia
  • Canada
  • Japan
  • Netherlands
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT01005901 on ClinicalTrials.gov