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A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

NCT01712516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1001

Last updated 2015-07-15

Study results available
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Summary

This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

QVA149

QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI

DRUG

QAB149

QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

DRUG

NVA237

NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.

DRUG

Placebo

Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 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
2012-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States
  • Colombia
  • Egypt
  • France
  • Guatemala
  • Hungary
  • Panama
  • Slovakia
  • Slovenia

Study Locations

More Related Trials

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 NCT01712516 on ClinicalTrials.gov