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Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients

NCT01119937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2013-01-18

Study results available
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Summary

This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .

Conditions

Interventions

DRUG

NVA237

50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®)

DRUG

Tiotropium

18µg capsules for inhalation, delivered via HandiHaler®

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-11-30

Countries

  • Japan

Study Locations

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Entities

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 NCT01119937 on ClinicalTrials.gov