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Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 28, 2011
Last updated: April 21, 2016
Last verified: April 2016

The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items;

  1. Unknown adverse drug reactions (ADRs)
  2. Incidence of ADRs to medical products in actual clinical practice
  3. Factors influencing safety of ambrisentan
  4. Factors influencing efficacy of ambrisentan
  5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)

Condition Intervention
Hypertension, Pulmonary
Drug: Ambrisentan

Study Type: Observational
Official Title: Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan [ Time Frame: 1 year ]
  • The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage [ Time Frame: 1 year ]
  • The number of adverse events and clinical course in subjects with hepatic dysfunction [ Time Frame: 1 year ]

Estimated Enrollment: 900
Study Start Date: December 2010
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed ambrisentan
Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period
Drug: Ambrisentan


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All Japanese subjects who have received ambrisentan for the first time for the treatment of pulmonary arterial hypertension (PAH) and have given their consent to participate in the study.

Inclusion Criteria:

  • Must use ambrisentan for the first time

Exclusion Criteria:

  • Subjects with hypersensitivity to ambrisentan
  • Subjects who is pregnant or might be pregnant
  • Subjects with severe hepatic disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01406327

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01406327     History of Changes
Other Study ID Numbers: 114782
Study First Received: July 28, 2011
Last Updated: April 21, 2016

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases processed this record on April 28, 2017