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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01392469
Date of registration: 10/05/2011
Prospective Registration: Yes
Primary sponsor: Novartis Pharmaceuticals
Public title: Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Patients
Scientific title: A Non-randomized, Multiple Dose, Three Treatment Period, Open-label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) Patients
Date of first enrolment: April 20, 2011
Target sample size: 21
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01392469
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Australia Belgium Germany Italy Lithuania Romania Turkey United Kingdom
United States
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key inclusion & exclusion criteria

Inclusion Criteria:

- Pulmonary arterial hypertension (PAH) patients in 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 WHO Diagnostic Group 1 such as congenital large or small
unrepaired systemic to pulmonary shunts, portal hypertension,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.

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Pulmonary Arterial Hypertension
Intervention(s)
Drug: Imatinib
Primary Outcome(s)
Measure: To evaluate the effect of QTI571 on pharmacokinetics of of sildenafil and bosentan in terms of the changes in AUCtau and Cmax in patients with Pulmonary Arterial Hypertension [Time Frame: 36 days]
Secondary Outcome(s)
Measure: Number of patients with adverse events as a measure of the safety and tolerability of QTI571 when co-administered with sildenafil and bosentan. [Time Frame: 36 days]
Measure: To evaluate the pharmacokinetics of QTI571 and its active metabolite in terms of AUCtau and Cmax in patients with Pulmonary Arterial Hypertension [Time Frame: 28 days]
Secondary ID(s)
2010-021344-17
CQTI571A2102
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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