NCT01392495

Brief Summary

This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2011

Typical duration for phase_3

Geographic Reach
7 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 13, 2015

Completed
Last Updated

August 10, 2015

Status Verified

July 1, 2015

Enrollment Period

2.8 years

First QC Date

July 11, 2011

Results QC Date

March 24, 2015

Last Update Submit

July 13, 2015

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertensionimatinib6MWD

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Adverse Events, Serious Adverse Events and Deaths

    Adverse event monitoring was conducted throughout the trial.

    144 weeks

Secondary Outcomes (3)

  • Change From Baseline in the Six Minute Walk Distance (6MWD)

    baseline, 144 weeks

  • Time to Clinical Worsening (TTCW) Endpoints

    144 weeks

  • Medical Resource Utilization

    144 weeks

Study Arms (1)

QTI571

EXPERIMENTAL

Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).

Drug: Imatinib

Interventions

ImatinibDRUG

200 mg or 400 mg qd

QTI571

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who completed in CQTI571A2102 clinical trial including all Study Completion assessments at the end of study visit met the eligibility criteria for that study and did not meet withdrawal criteria for safety reasons during study conduct

You may not qualify if:

  • Patients with left ventricular ejection fraction (LVEF) \< 45%
  • Patients with thrombocytopenia, platelet count \< 50 x109/L (50 x 103/µL).
  • Patients with uncontrolled systemic arterial hypertension, systolic pressure \> 160 mmHg or diastolic pressure \> 90 mmHg.
  • Patients with a QTcF \> 450 ms for males and \> 470 ms for females in the absence of right bundle branch block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Novartis Investigative Site

Mineola, New York, 11501, United States

Location

Novartis Investigative Site

Darlinghurst, New South Wales, 2010, Australia

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Roma, RM, 00161, Italy

Location

Novartis Investigative Site

Vilnius, LT-08661, Lithuania

Location

Novartis Investigative Site

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

  • Frost AE, Barst RJ, Hoeper MM, Chang HJ, Frantz RP, Fukumoto Y, Galie N, Hassoun PM, Klose H, Matsubara H, Morrell NW, Peacock AJ, Pfeifer M, Simonneau G, Tapson VF, Torres F, Dario Vizza C, Lawrence D, Yang W, Felser JM, Quinn DA, Ghofrani HA. Long-term safety and efficacy of imatinib in pulmonary arterial hypertension. J Heart Lung Transplant. 2015 Nov;34(11):1366-75. doi: 10.1016/j.healun.2015.05.025. Epub 2015 Jun 11.

    PMID: 26210752DERIVED

  • Hoeper MM, Barst RJ, Bourge RC, Feldman J, Frost AE, Galie N, Gomez-Sanchez MA, Grimminger F, Grunig E, Hassoun PM, Morrell NW, Peacock AJ, Satoh T, Simonneau G, Tapson VF, Torres F, Lawrence D, Quinn DA, Ghofrani HA. Imatinib mesylate as add-on therapy for pulmonary arterial hypertension: results of the randomized IMPRES study. Circulation. 2013 Mar 12;127(10):1128-38. doi: 10.1161/CIRCULATIONAHA.112.000765. Epub 2013 Feb 12.

    PMID: 23403476DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

June 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 10, 2015

Results First Posted

July 13, 2015

Record last verified: 2015-07

Locations

GB(1)AU(1)BE(1)DE(1)US(1)IT(1)LI(1)