NCT01117987 - Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) | Biotech Hunter

Enrollment

144

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions

Pulmonary Arterial Hypertension

Interventions

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.

DRUG

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.

Trial Locations (59)

3000

Novartis Investigative Site, Leuven

9007

Novartis Investigative Site, Sankt Gallen

10029

Novartis Investigative Site, New York

11501

Novartis Investigative Site, Mineola

12552

Novartis Investigative Site, Berlin

12683

Novartis Investigative Site, Berlin

15213

Novartis Investigative Site, Pittsburgh

20246

Novartis Investigative Site, Hamburg

27100

Novartis Investigative Site, Pavia

27710

Novartis Investigative Site, Durham

28041

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

30625

Novartis Investigative Site, Hanover

33331

Novartis Investigative Site, Weston

35039

Novartis Investigative Site, Marburg

39008

Novartis Investigative Site, Santander

41013

Novartis Investigative Site, Seville

44195

Novartis Investigative Site, Cleveland

45219

Novartis Investigative Site, Cincinnati

50937

Novartis Investigative Site, Cologne

53215

Novartis Investigative Site, Milwaulkee

55905

Novartis Investigative Site, Rochester

60637

Novartis Investigative Site, Chicago

63110

Novartis Investigative Site, St Louis

66421

Novartis Investigative Site, Homburg

68131

Novartis Investigative Site, Omaha

69120

Novartis Investigative Site, Heidelberg

73104

Novartis Investigative Site, Oklahoma City

77030

Novartis Investigative Site, Houston

81377

Novartis Investigative Site, München

85013

Novartis Investigative Site, Phoenix

90095

Novartis Investigative Site, Los Angeles

92141

Novartis Investigative Site, Clamart

93053

Novartis Investigative Site, Regensburg

94143

Novartis Investigative Site, San Francisco

97062

Novartis Investigative Site, Tualatin

97080

Novartis Investigative Site, Würzburg

35294-0006

Novartis Investigative Site, Birmingham

A-1090

Novartis Investigative Site, Vienna

T1Y 6J4

Novartis Investigative Site, Calgary

T6G 2B7

Novartis Investigative Site, Edmonton

N6A 4G5

Novartis Investigative Site, London

01307

Novartis Investigative Site, Dresden

00161

Novartis Investigative Site, Roma

980-8574

Novartis Investigative Site, Sendai

701-1192

Novartis Investigative Site, Okayama

431-3192

Novartis Investigative Site, Hamamatsu

113-8655

Novartis Investigative Site, Bunkyo-ku

181-8611

Novartis Investigative Site, Mitaka

1081 HV

Novartis Investigative Site, Amsterdam

110 744

Novartis Investigative Site, Seoul

120-752

Novartis Investigative Site, Seoul

135-710

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

CB23 3RE

Novartis Investigative Site, Cambridge

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

S10 2JF

Novartis Investigative Site, Sheffield

NW3 3QG

Novartis Investigative Site, London