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Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Ambrisentan 5 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com

Summary

It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel group, 16 week study will compare the safety and efficacy of ambrisentan 5 milligrams (mg) versus placebo in subjects with inoperable CTEPH. The study will enrol 160 subjects, to assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out rate.

Clinical Details

Official title: A Randomised, Multicentre, Double-Blind, Placebo-Controlled Study Of Ambrisentan In Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in 6-minute walk distance (6MWD)

Secondary outcome:

Change from baseline in pulmonary vascular resistance (PVR)

Change from baseline in Functional Class (FC)

Change from baseline in Borg CR10 Scale (BCR10S)

Change from baseline in Clinical worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Change from baseline in other haemodynamics

Change from baseline in N-terminal pro-B-type natriuretic peptide( NT-proBNP)

Change from baseline in Quality of Life as measured by SF-36 Health Survey (SF-36)

Incidence of adverse events and serious adverse events

Change from baseline in haemoglobin or haematocrit levels

Safety as assessed by liver testing abnormalities

Safety as assessed by vital signs measurements

Safety as assessed by laboratory test measurements

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed written informed consent prior to beginning study-related procedures.

- Subject must be between 18-80 years of age, inclusive, at the Screening Visit.

- Subjects must have a diagnosis of CTEPH at an expert centre with a positive V/Q and

CT angiogram and a pulmonary angiogram if available within 6 months prior to screening.

- Subject must meet all of the following haemodynamic criteria by means of a RHC within

3 months prior to screening: Mean pulmonary artery pressure (mPAP) of >25 millimeters of mercury (mmHg), Pulmonary vascular resistance (PVR) >400 dynes. sec/centimetre (cm)^5, Pulmonary capillary wedge pressure (PCWP) or Left ventricle end diastolic pressure (LVEDP) of <15 mmHg.

- Subjects must have previously been judged inoperable due to the obstruction being

surgically inaccessible (i. e. distal disease) by an expert multidisciplinary team which must include at least one cardiology or respiratory consultant, and one consultant PEA surgeon. For countries with CTEPH expert centers [including at least a surgeon with sound experience performing Pulmonary Endarterectomy (PEAs)] the expert team will be the local expert centre. For countries without a CTEPH surgical expert center a central adjudication committee will assess the operability of the subjects during the screening period.

- Subject must walk a distance of >150 Meters (m) and < 475 m at the screening visit.

- Subject must have a current diagnosis of being in WHO Functional Class II or III.

- Subject, with or without supplemental oxygen, must have a resting arterial oxygen

saturation (SaO2) > 92% as measured by pulse oximetry at the Screening Visit.

- Subjects must have received anticoagulation for a minimum of 3 months prior to

Screening

- Female subject of childbearing potential must agree to use 2 reliable methods of

contraception from the Screening Visit until study completion and for at least 30 days following the last dose of Investigational Product

- Subject must agree not to participate in a clinical study involving another

investigational drug or device throughout this study.

- Subject must be competent to understand the information given in the Institutional

Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent form (ICF) and must sign the form prior to the initiation of any study procedures. Exclusion Criteria:

- Subject received previous Pulmonary arterial hypertension (PAH) therapy

(Phosphodiesterase type 5 [PDE5i], Endothelin receptor antagonist [ERA], chronic prostanoid use)

- Subject has previously discontinued other ERA in either another clinical study or

commercial product for safety or tolerability reasons other than for liver function abnormalities.

- Subject has a known hypersensitivity to the Investigational Products, the

metabolites, or formulation excipients

- Subject has previously undergone a pulmonary endarterectomy or a balloon pulmonary

angioplasty

- Subject receiving intravenous inotropes within 2 weeks prior to the Screening Visit

(e. g. dopamine, dobutamine)

- Subjects receiving Calcium Channel Blockers or 5-hydroxy-3-methylglutaryl-coenzyme A

5-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (i. e., statins) on an unstable dose 4 weeks prior to the Screening Visit (to be eligible subjects must not have changed their dose <4 weeks prior to the screening visit)

- Subject has not enrolled in an exercise training program for cardiopulmonary

rehabilitation within 12 weeks prior to the Screening Visit and must agree not to enroll in an exercise training program for pulmonary rehabilitation during the Screening Period and the first 16 weeks of the study. Subjects enrolled in an exercise program for pulmonary rehabilitation 12 weeks prior to screening may enter the study if they agree to maintain their current level of rehabilitation for the first 16 weeks of the study.

- Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) > 3x Upper

limit of normal (ULN)

- Bilirubin > 1. 5xULN (>35% direct bilirubin)

- Subject has severe renal impairment [estimated creatinine clearance <30

millilitre/minute (mL/min)] at the Screening Visit

- Subject has moderate - severe hepatic impairment (Child-Pugh class B-C with or

without cirrhosis) at the Screening Visit

- Subject has clinically significant anaemia: Hemoglobin (Hb) < 10 grams/decilitre

(g/dL)

- Subjects with bleeding disorders or significant active peptic ulceration in the

opinion of the investigator

- Subject has uncontrolled hypertension (>180/110 mmHg) at screening

- Subject has severe hypotension (<90/50 mmHg) at screening

- Subject has had an acute myocardial infarction within the last 90 days prior to

screening

- Subject has, in the opinion of the investigator, clinically significant aortic or

mitral valve disease; pericardial constriction; restrictive or congestive cardiomyopathy; life-threatening cardiac arrhythmias; significant left ventricular dysfunction (ejection fraction <50% of normal); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; fluid depletion.

- Subject with significant pulmonary disease Forced expiratory volume in 1 second

(FEV1) <70% of predicted): Chronic obstructive pulmonary disease (COPD), Emphysema, evidence of fibrotic lung disease on imaging

- Subject has clinically significant fluid retention in the opinion of the investigator

- Subject with significant obesity [Body mass index (BMI) ≥35], cardiovascular,

musculoskeletal or any other condition that in the opinion of the investigator may involve an impairment of exercise capacity or the performance of the 6MWD test (e. g. previous history of hip/knee surgery, lower limb ulcers associated with autoimmune diseases)

- Subject with cardiovascular, liver, renal, haematologic, gastrointestinal,

immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the investigational product or severely limit the lifespan of the subject other than the condition being studied

- Subjects with a prior malignancy whose cancer is expected to require additional

active treatment in the next 2 years and whose prior malignancy would prevent them from fully participating in the study

- Female subject who is pregnant or breastfeeding

- Subject has demonstrated noncompliance with previous medical regimens

- Subject has a recent (within 1 year) history of abusing alcohol or illicit drugs

- Subject has participated in a clinical study involving another investigational drug

or device within 4 weeks before the Screening Visit.

Locations and Contacts

US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Ciudad Autonoma de Buenos Aires C1181ACH, Argentina; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Corrientes W3400AMZ, Argentina; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Santa Fe, Argentina; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Graz A-8036, Austria; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Innsbruck A-6020, Austria; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Vienna 1090, Austria; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Beijing 100038, China; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Beijing 100037, China; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Beijing 100020, China; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Shanghai 200433, China; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Praha 2 128 08, Czech Republic; Completed

GSK Investigational Site, Aichi 466-8560, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Fukuoka 812-8582, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Hokkaido 060-8648, Japan; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Hyogo 650-0017, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Miyagi 980-8574, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Tochigi 329-0498, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Tokyo 113-8655, Japan; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Tokyo 181-8611, Japan; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Seoul 110-744, Korea, Republic of; Completed

GSK Investigational Site, Seoul 120-752, Korea, Republic of; Completed

GSK Investigational Site, Seoul 135-710, Korea, Republic of; Completed

GSK Investigational Site, Amsterdam 1081 HV, Netherlands; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Kemerovo 650002, Russian Federation; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Novosibirsk 630055, Russian Federation; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Tomsk 634012, Russian Federation; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Barcelona 08036, Spain; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Madrid 28041, Spain; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Majadahonda (Madrid) 28222, Spain; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Sevilla 41013, Spain; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Cambridge CB23 3RE, United Kingdom; Terminated

GSK Investigational Site, Clydebank G81 4DY, United Kingdom; Terminated

GSK Investigational Site, London NW3 2QH, United Kingdom; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Edmonton, Alberta T6G 2B7, Canada; Terminated

GSK Investigational Site, Heidelberg, Baden-Wuerttemberg 69126, Germany; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Regensburg, Bayern 93053, Germany; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Wuerzburg, Bayern 97074, Germany; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Wuhan, Hubei 430022, China; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Boston, Massachusetts 02118, United States; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Hannover, Niedersachsen 30625, Germany; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Monterrey NL, Nuevo León 64718, Mexico; Completed

GSK Investigational Site, London, Ontario N6A 5W9, Canada; Terminated

GSK Investigational Site, Homburg, Saarland 66421, Germany; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Dresden, Sachsen 01307, Germany; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Leipzig, Sachsen 04103, Germany; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Rosario, Santa Fe S2000ODA, Argentina; Not yet recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Xian, Shaanxi 710061, China; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com

GSK Investigational Site, Dallas, Texas 75390-8550, United States; Completed

Additional Information

Starting date: September 2013
Last updated: February 19, 2015

Page last updated: August 23, 2015

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