A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

NCT ID: NCT01894022

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-23
• Study Completion Date: 2015-11-18

Brief Summary

This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: the product is approved locally for use in inoperable CTEPH patients; development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities; or the investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ambrisentan Arm

All subjects will receive ambrisentan initially at a dose of 5 mg once daily (OD). Based on the investigator's best judgment, the subject may continue on 5 mg OD, or be up-titrated to 10 mg OD. The dose may also be adjusted back to 5 mg OD at investigator discretion.

Group Type: EXPERIMENTAL

Ambrisentan 5 mg

Intervention Type: DRUG

Round, white, film-coated, immediate-release tablets, containing 5 mg ambrisentan. Subjects will be dosed orally once daily. Subjects may receive 5mg, or 10 mg of ambrisentan OD.

Interventions

Ambrisentan 5 mg

Round, white, film-coated, immediate-release tablets, containing 5 mg ambrisentan. Subjects will be dosed orally once daily. Subjects may receive 5mg, or 10 mg of ambrisentan OD.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have been randomized to the protocol for AMB115811 and have met one of the following: Completed the Week 16 visit in AMB115811; Or Prematurely withdrew from AMB115811 for whatever reason (where investigational product [IP] has been stopped due to safety or efficacy reasons, the subject may still enter into the open label study regardless of what treatment they are receiving [other treatments will not be supplied by the sponsor]. The investigator will decide whether or not the subject will receive the IP
• Subject is able and willing to give written informed consent. As part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counseled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
• Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the Investigators Brochure and product label for PAH indication.
• In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category

Exclusion Criteria

• Subject meeting any of the following criteria must not receive ambrisentan, however may still be followed-up as part of the study and be treated according to best clinical practice as decided by the investigator:
• Subject has a known hypersensitivity to the Investigational Products, the metabolites, or formulation excipients
• Female subjects who are pregnant or breastfeeding or no-longer agree to comply with using effective contraception as defined in the protocol.
• Subjects with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >= 3x Upper limit of normal (ULN)
• Subjects with bilirubin >= 2xULN (>35% direct bilirubin)
• Subjects with severe renal impairment (estimated creatinine clearance <30 millilitre per minute (mL/min) assessed within the previous 45 days) at the point of transition from Study AMB115811
• Subject has moderate - severe hepatic impairment (Child-Pugh class B-C with or without cirrhosis) at the point of transition from study AMB115811
• Subject with clinically significant fluid retention in the opinion of the investigator
• Subject with clinically significant anemia in the opinion of the investigator
• Subjects who are to enter another clinical trial or be treated with another investigational product after exiting Study AMB115811.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Corrientes, , Argentina

GSK Investigational Site

Santa Fe, , Argentina

GSK Investigational Site

Graz, , Austria

GSK Investigational Site

Innsbruck, , Austria

GSK Investigational Site

Vienna, , Austria

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Wuhan, Hubei, China

GSK Investigational Site

Xi'an, Shaanxi, China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Regensburg, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Homburg, Saarland, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Ashkelon, , Israel

GSK Investigational Site

Zrifin, , Israel

GSK Investigational Site

Aichi, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Miyagi, , Japan

GSK Investigational Site

Tochigi, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Monterrey NL, Nuevo León, Mexico

GSK Investigational Site

Amsterdam, , Netherlands

GSK Investigational Site

Kemerovo, , Russia

GSK Investigational Site

Tomsk, , Russia

GSK Investigational Site

Riyadh, , Saudi Arabia

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Majadahonda (Madrid), , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Cambridge, , United Kingdom

GSK Investigational Site

Clydebank, , United Kingdom

GSK Investigational Site

London, , United Kingdom

Countries

United States; Argentina; Austria; Canada; China; Czechia; Germany; Israel; Japan; Mexico; Netherlands; Russia; Saudi Arabia; South Korea; Spain; United Kingdom

Other Identifiers

116457

Identifier Type: -

Identifier Source: org_study_id