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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01406327
First received: July 28, 2011
Last updated: July 24, 2014
Last verified: June 2013

July 28, 2011
July 24, 2014
December 2010
January 2020   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01406327 on ClinicalTrials.gov Archive Site
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Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)

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.)
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Observational
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Probability Sample

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.

Hypertension, Pulmonary
Drug: Ambrisentan
Subjects prescribed ambrisentan
Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period
Intervention: Drug: Ambrisentan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
April 2020
January 2020   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01406327
114782
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP