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OpenTrials
Completed

NCT Number: NCT01406327

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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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambrisentan

Drug

Ambrisentan

Primary outcomes

  1. The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan

    Time frame: 1 year

  2. The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage

    Time frame: 1 year

  3. The number of adverse events and clinical course in subjects with hepatic dysfunction

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2011
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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