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Clinical Trials/EUCTR2019-000325-49-DE
EUCTR2019-000325-49-DE
Active, not recruiting
Phase 1

A randomized, subjects and investigator blinded, placebo controlled parallel group study to assess the mode of action of QBW251 in patients with Chronic Obstructive Pulmonary Disease (COPD)

ovartis Pharma AG0 sites100 target enrollmentApril 9, 2020
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Pharma AG
Enrollment
100
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 9, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients who have signed an Informed Consent Form prior to initiation
  • •of any study\-related procedure.
  • •Male and female adults aged \=40 years at screening.
  • •Patients with stable COPD, stages GOLD 2\-3, according to the current
  • •GOLD strategy (GOLD 2019\) at screening.
  • •Patients with a post\-bronchodilator FEV1/FVC \< 0\.70 at screening
  • •Patients with airflow limitation indicated by a post\-bronchodilator FEV1
  • •\= 30% and FEV1 \< 80% of the predicted normal at Screening who must
  • •have had at least 2 documented moderate or at least 1 documented
  • •severe exacerbation(s) between January 2019 to study screening.

Exclusion Criteria

  • •Patients with a history of long\-QT syndrome or whose QTcF interval at
  • •screening (Fridericia method) is prolonged (QTcF \>450 ms in males,
  • •\>460 ms in females).
  • •Patients who have a clinically significant ECG abnormality before
  • •randomization.
  • •Clinical laboratory values abnormalities (including Gamma GT, AST,
  • •ALT, total bilirubin or creatinine) considered as clinically significant in
  • •the opinion of the Investigator at screening.
  • •Patients who have clinically significant renal, cardiovascular (such as
  • •but not limited to unstable ischemic heart disease, NYHA Class III/IV

Outcomes

Primary Outcomes

Not specified

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