Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-20

Study Completion Date

2012-10-25

Brief Summary

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The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib + Bosentan + Sildenafil

Participants received treatment with bosentan 125 milligrams (mg) twice daily and sildenafil thrice daily for 8 days in treatment period 1. Participants were on the same sildenafil dose level (20, 40, 50 or 60 mg) they had been at study entry which was well tolerated in conjunction with bosentan. Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2. Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.

Group Type EXPERIMENTAL

Imatinib

Intervention Type DRUG

Film coated tablets, oral administration

Sildenafil

Intervention Type DRUG

Oral Administration

Bosentan

Intervention Type DRUG

Oral Administration

Interventions

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Imatinib

Film coated tablets, oral administration

Intervention Type DRUG

Sildenafil

Oral Administration

Intervention Type DRUG

Bosentan

Oral Administration

Intervention Type DRUG

Other Intervention Names

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QTI571

Eligibility Criteria

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Inclusion Criteria

* Participants with Pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Diagnostic Group 1, with pulmonary vascular resistance \> 800 dyne\*sec\*cm\^-5,
* On stable doses of bosentan and sildenafil

Exclusion Criteria

* Other diagnosis of PAH in World Health Organization (WHO) Diagnostic Group 1 such as congenital large or small unrepaired systemic to pulmonary shunts, portal hypertension, Human Immunodeficiency Virus (HIV) infection, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic teleangiectasia, hemoglobinopathies, myeloproliferative disorders, veno-occlusive pulmonary disease
* Significant lung diseases not related to PAH
* Significant cardiovascular system disorders, hematological system disorders, liver insufficiency
* Significant diseases in other organ system.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No