Clinical Trial: Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension

Brief Summary: This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: 204 weeks ]

Adverse event monitoring was conducted throughout the study.


Original Primary Outcome: Number of patients with Adverse Events as a measure of the safety and tolerability of QTI571 [ Time Frame: 672 days ]

Current Secondary Outcome:

  • Change From Core Study Baseline in Six-Minute Walk Distance (6MWD) [ Time Frame: core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks ]
    A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).
  • Percentage of Participants With Incidence of Clinical Worsening Events [ Time Frame: 204 weeks ]
    Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO & 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.


Original Secondary Outcome:

  • Change in Six-Minute Walk Distance (6MWD) from baseline [ Time Frame: 672 days ]
  • Time to clinical worsening (TTCW) endpoints [ Time Frame: 672 days ]


Information By: Novartis

Dates:
Date Received: May 3, 2010
Date Started: April 2010
Date Completion:
Last Updated: July 24, 2015
Last Verified: July 2015