Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan

Phase 3CompletedNCT02042014

Novartis Pharmaceuticals8 enrolled

Overview

To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Pulmonary Arterial Hypertension

Interventions

QTI571DRUG

QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan. * Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator. Exclusion Criteria: * Patient has been permanently discontinued from QTI571 study treatment in the parent study. * Concomitant use of oral vitamin K antagonist medication.

Locations (3)

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site

Mitaka, Tokyo, Japan

Outcomes

Primary Outcomes

Serious Adverse Events

All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.

Time frame: Approximately 2.9 years

Data from ClinicalTrials.gov

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