CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 257 enrolled
Drug / intervention
indacaterol/glycopyrrolate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00558285
NCT00558285Phase 2Completed
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A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Novartis·interventional·Posted Nov 14, 2007·Updated Nov 30, 2012

In Brief

A Phase 2 clinical trial evaluating indacaterol/glycopyrrolate, indacaterol, and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 257 participants across 40 sites in 8 countries.

Detailed Summary

An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesAustralia, Belgium, Canada, France, Germany, Italy, Spain, Turkey (Türkiye)
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2007
Enrollment StartNov 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.6 years ago

Interventions

indacaterol/glycopyrrolatedrug

Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

indacateroldrug

Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

glycopyrrolatedrug

Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

placebodrug

Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.