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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00303459 |
This study will investigate the effects of the combination of bosentan and sildenafil. Patients with symptomatic PAH treated with a stable dose of sildenafil equal to or greater tha 20 mg t.i.d. for at least 12 weeks will be randomized to placebo or bosentan 125 mg b.i.d. All randomized patients will be treated with study drug until the predefined target number of morbidity/mortality events is reached.
Condition | Intervention | Phase |
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Pulmonary Hypertension |
Drug: bosentan Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study |
Estimated Enrollment: | 250 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Bosentan
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Drug: bosentan
bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.
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B: Placebo Comparator
Placebo
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Drug: placebo
Matching bosentan placebo/b.i.d.
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males or females >=12 years of age (except for countries where this age limit is contrary to specific regulatory requirements).
Women of childbearing potential must have a negative pre-treatment pregnancy test and must use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.
O Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide. O Intra-uterine devices. O Oral, transdermal, injectable or implantable contraceptives only in combination with a barrier method.
Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or documented surgically or naturally sterile. 3)Patients with symptomatic PAH 4)Patients with the following types of PAH belonging to WHO Group I: a. Idiopathic (IPAH) b. Familial (FPAH) c. Associated with (APAH): i. Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii. Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair iii. Drugs and toxins 5)PAH diagnosed by right heart catheter showing:
Pulmonary capillary wedge pressure (PCWP) =< 15 mm Hg or left ventricular end diastolic pressure (LVEDP) =< 15 mmHg If both PCWP and LVEDP are available then the LVEDP value is retained for inclusion.
6)Treatment with a stable dose of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to randomization (no sildenafil dosage adjustment should occur in this period) 7)150 m =< 6MWT =< 480 m, documented by 2 tests with second 6MWT within 15% of first 6MWT distance or a third test required
Exclusion Criteria :
3) 8)Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) < 0.5 9)Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C 10)Known HIV infection 11)Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements or that may interfere with the safety or the evaluation of the study, such as chronic infection, chronic renal failure etc. 12)Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements 13)Pregnancy or breast-feeding 14)Condition that prevents compliance with the protocol or adherence to therapy 15)Systolic blood pressure < 85 mmHg 16)Body weight < 40 kg 17)Hemoglobin <75% of the lower limit of the normal range 18)Aspartate aminotransferase (AST) and/or alanine aminotransferase ALT > 1.5 times the upper limit of normal ranges 19)Known hypersensitivity or history of drug-related adverse events with bosentan (e.g. increase in liver function test results [LFTs]), or any of the excipients of its formulation 20)Receipt of an investigational product other than sildenafil within 3 months before start of study treatment 21)Treatment with endothelin receptor antagonists (ERAs), prostanoids or phosphodiesterase (PDE) 5 inhibitors other than sildenafil within 3 months prior to randomization 22)Concomitant systemic treatment within 1 week prior to randomization with
Contact: Mostafa Chouikh | 617-600-4810 | mostafa.chouikh@actelion.com |
Responsible Party: | Actelion ( Frederic Bodin, MD ) |
Study ID Numbers: | AC-052-414, COMPASS-2 |
Study First Received: | March 16, 2006 |
Last Updated: | August 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00303459 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; European Union: European Medicines Agency |
Pulmonary Arterial Hypertension Pulmonary Hypertension Antihypertensive Agents bosentan Tracleer sildenafil |
endothelin receptor antagonist Combination Drug Therapy Outcome Assessment Randomized Controlled Trial Multicenter Study |
Vasodilator Agents Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Idiopathic Pulmonary Hypertension |
Vascular Diseases Sildenafil Cardiovascular Agents Antihypertensive Agents Bosentan Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Enzyme Inhibitors Sildenafil Cardiovascular Agents Antihypertensive Agents Bosentan |
Pharmacologic Actions Phosphodiesterase Inhibitors Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Therapeutic Uses Cardiovascular Diseases Hypertension |