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Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

NCT01697696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2016-03-16

Study results available
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Summary

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

NVA237

NVA237 will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI

DRUG

Long-acting beta 2-agonist (LABA)

QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI

DRUG

Placebo

Placebo to match QAB149

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
2012-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01697696 on ClinicalTrials.gov