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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)

Brief 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.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of AE and SAE in patients with PAH over a two year period [ Time Frame: Two years ]

Adverse Events, Serious Adverse Events and all safety Assessments


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cmax [ Time Frame: 16 weeks ]
    Cmax is the observed maximum plasma concentration following drug administration
  • Tmax [ Time Frame: 16 Weeks ]
    Tmax is the time to reach the maximum concentration after drug administration
  • AUClast [ Time Frame: 16 weeks ]
    AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
  • AUCtau [ Time Frame: 16 Weeks ]
    The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau [mass x time / volume]
  • Change from Baseline in Six Minute Walk Test (6MWT) [ Time Frame: Two Years ]
    Six Minute Walk Distance (6MWD)
  • Change from Baseline in Echocardiography Measurements [ Time Frame: Two Years ]
    Key right ventricular (RV) function endpoints with echocardiography will include but not limited to tricuspid annular peak systolic velocity (TA S'), RV Tei index and RV fractional area change.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: October 12, 2016
Date Started: October 2, 2017
Date Completion: October 2, 2019
Last Updated: April 4, 2017
Last Verified: April 2017