MedTrace Logo

A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

NCT01682863 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 614

Last updated 2016-03-30

Study results available
· View outcomes & findings →

Summary

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

QVA149

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

DRUG

QVA149

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

DRUG

QAB149

QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI

DRUG

Placebo

To mimic QAB149

Sponsors & Collaborators

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
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • Bulgaria
  • Finland
  • Hungary
  • Puerto Rico
  • Romania
  • Spain

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 NCT01682863 on ClinicalTrials.gov