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

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ClinicalTrials.gov Identifier: NCT01406327
Recruitment Status : Active, not recruiting
First Posted : August 1, 2011
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Hypertension, Pulmonary Drug: Ambrisentan

Study Design

Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Other
Time Perspective: Other
Official Title: Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)
Actual Study Start Date : December 14, 2010
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020


Groups and Cohorts

Group/Cohort Intervention/treatment
Subjects prescribed ambrisentan
Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period
Drug: Ambrisentan
Ambrisentan


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406327


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01406327     History of Changes
Other Study ID Numbers: 114782
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Ambrisentan
Antihypertensive Agents