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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01117987
Other study ID # CQTI571A2301E1
Secondary ID 2009-018167-26
Status Terminated
Phase Phase 3
First received May 3, 2010
Last updated July 24, 2015
Start date April 2010
Est. completion date April 2014

Study information

Verified date July 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySwitzerland: SwissmedicKorea: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices AgencyCanada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 144
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments

- Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments

Exclusion Criteria:

- Patients with a pulmonary capillary wedge pressure > 15 mmHg at time of Study Completion assessments in core protocol CQTI571A2301. If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place.

- LVEF < 45%

- Patients with thrombocytopenia, platelet count < 50E9/L (50E3/µL)

- Patients with uncontrolled systemic arterial hypertension, systolic > 160 mmHg or diastolic > 90 mmHg

- Patients with a QTcF > 450 ms for males and > 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed)

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Imatinib
Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.
Placebo
To preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.

Locations

Country Name City State
Austria Novartis Investigative Site Wien
Belgium Novartis Investigative Site Leuven
Canada Novartis Investigative Site Calgary Alberta
Canada Novartis Investigative Site Edmonton Alberta
Canada Novartis Investigative Site London Ontario
France Novartis Investigative Site Clamart Cedex
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Homburg
Germany Novartis Investigative Site Köln
Germany Novartis Investigative Site Marburg
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Regensburg
Germany Novartis Investigative Site Würzburg
Italy Novartis Investigative Site Pavia (pv)
Italy Novartis Investigative Site Roma RM
Japan Novartis Investigative Site Bunkyo-ku Tokyo
Japan Novartis Investigative Site Hamamatsu Shizuoka
Japan Novartis Investigative Site Mitaka-city Tokyo
Japan Novartis Investigative Site Okayama-city Okayama
Japan Novartis Investigative Site Sendai-city Miyagi
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul Korea
Netherlands Novartis Investigative Site Amsterdam
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Malaga Andalucia
Spain Novartis Investigative Site Santander Cantabria
Spain Novartis Investigative Site Sevilla Andalucia
Switzerland Novartis Investigative Site St. Gallen
United Kingdom Novartis Investigative Site Cambridge Cambridgeshire
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Newcastle Upon Tyne Newcastle
United Kingdom Novartis Investigative Site Sheffield South Yorkshire
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Durham North Carolina
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Milwaulkee Wisconsin
United States Novartis Investigative Site Mineola New York
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Oklahoma City Oklahoma
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Phoenix Arizona
United States Novartis Investigative Site Pittsburgh Pennsylvania
United States Novartis Investigative Site Rochester Minnesota
United States Novartis Investigative Site San Francisco California
United States Novartis Investigative Site St. Louis Missouri
United States Novartis Investigative Site Tualatin Oregon
United States Novartis Investigative Site Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events, Serious Adverse Events and Deaths Adverse event monitoring was conducted throughout the study. 204 weeks Yes
Secondary Change From Core Study Baseline in Six-Minute Walk Distance (6MWD) A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002). core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks No
Secondary Percentage of Participants With Incidence of Clinical Worsening Events 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. 204 weeks No
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