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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01406327
First received: July 28, 2011
Last updated: August 11, 2011
Last verified: August 2011
History of Changes
  Purpose

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:

Drug Information available for: Ambrisentan
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The number of adverse events and clinical course in subjects with hepatic dysfunction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: December 2010
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: January 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

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406327

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01406327     History of Changes
Other Study ID Numbers: 114782
Study First Received: July 28, 2011
Last Updated: August 11, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
 Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013