Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Patients
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392469
First received: May 10, 2011
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
This study will investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to pulmonary arterial hypertension patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Arterial Hypertension |
Drug: Imatinib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
pulmonary arterial hypertension
MedlinePlus related topics:
High Blood Pressure
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | April 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: QTI571 | Drug: Imatinib |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392469
Locations
| United States, Florida | |
| Novartis Investigative Site | |
| Tampa, Florida, United States, 33606 | |
| Novartis Investigative Site | |
| Weston, Florida, United States, 33331 | |
| United States, New York | |
| Novartis Investigative Site | |
| Mineola, New York, United States, 11501 | |
| Australia, New South Wales | |
| Novartis Investigative Site | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Belgium | |
| Novartis Investigative Site | |
| Leuven, Belgium, 3000 | |
| Germany | |
| Novartis Investigative Site | |
| Berlin, Germany, 12683 | |
| Novartis Investigative Site | |
| Hannover, Germany, 30625 | |
| Italy | |
| Novartis Investigative Site | |
| Roma, RM, Italy, 00161 | |
| Lithuania | |
| Novartis Investigative Site | |
| Vilnius, Lithuania, LT-08661 | |
| United Kingdom | |
| Novartis Investigative Site | |
| London, United Kingdom, NW3 2PR | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01392469 History of Changes |
| Other Study ID Numbers: | CQTI571A2102, 2010-021344-17 |
| Study First Received: | May 10, 2011 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Romania: National Medicines Agency Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Pulmonary arterial hypertension pulmonary vascular resistance imatinib bosentan sildenafil |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Bosentan Sildenafil Imatinib Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013