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Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPD

NCT01584505 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2021-10-29

No results posted yet for this study

Summary

Cardiac Safety Study

Conditions

  • Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

CHF1535 + CHF5992 dose 1 BID

CHF1535 + CHF5992 dose 1 BID for 14 days

DRUG

CHF1535 + CHF5992 dose2 BID

CHF1535 + CHF5992 dose 2 BID for 14 days

DRUG

CHF1535 daily dose

CHF1535 daily dose for 14 days

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Hans-Jörg Kampschulte, MD · Arzt für Innere Medizin und Pneumologie, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-09-30
Completion
2013-01-31

Countries

  • Bulgaria
  • Germany
  • Hungary
  • Poland
  • Russia
  • United Kingdom

Study Locations

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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 NCT01584505 on ClinicalTrials.gov