Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients

Last updated: December 9, 2020
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

2

Condition

Pulmonary Arterial Hypertension

Stress

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02939599
CQCC374X2201E1
  • Ages > 18
  • All Genders

Study Summary

This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in adult patients with PAH. This study provides the patients who completed the QCC374X2201 study with the option to continue receiving QCC374. The study will monitor the long-term safety, tolerability and efficacy of QCC374 in patients with PAH.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Subject was enrolled in the QCC374X2201 study and completed per protocol

Exclusion

Exclusion Criteria:

  • Subjects who have started receiving prostacyclin (epoprostenol), prostacyclin analogs (i.e. trepostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e.selexipag) since the last study drug intake in the QCC374X2201 study.
  • Females who are pregnant, or who plan to become pregnant during the study, or who arebreastfeeding
  • Any known factor or disease that may interfere with treatment compliance or studyconduct (i.e. drug or alcohol dependence)
  • Subjects who withdrew consent from the study QCC374X2201

Study Design

Total Participants: 5
Study Start date:
February 01, 2018
Estimated Completion Date:
November 06, 2018

Connect with a study center

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cambridge, Cambridgeshire CB23 3RE
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania 15261
    United States

    Site Not Available

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