Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01808313
First received: February 28, 2013
Last updated: April 27, 2015
Last verified: April 2015
Results First Received: April 2, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Vascular Disease
Intervention: Drug: ambrisentan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 134 participants were enrolled and received at least one dose of study medication. 133 participants comprised the Intent-to-Treat (ITT) Population (all participants that received at least one dose of study treatment and had an efficacy assessment performed both at Baseline and after administration of the study treatment).

Reporting Groups
  Description
Ambrisentan Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.

Participant Flow:   Overall Study
    Ambrisentan  
STARTED     133  
COMPLETED     123  
NOT COMPLETED     10  
Adverse Event                 5  
Protocol Violation                 2  
Met Protocol-defined Stopping Criteria                 1  
Lost to Follow-up                 1  
Physician Decision                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ambrisentan Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.

Baseline Measures
    Ambrisentan  
Number of Participants  
[units: participants]
  133  
Age  
[units: Years]
Mean (Standard Deviation)
  36.1  (10.25)  
Gender  
[units: Participants]
 
Female     113  
Male     20  
Race/Ethnicity, Customized  
[units: Particiopants]
 
Asian-East Asian Heritage     133  



  Outcome Measures
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1.  Primary:   Change From Baseline in 6-minutes Walk Test (6MWT) at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Change From Baseline in 6MWT at Week 24   [ Time Frame: Baseline and Week 24 ]

3.  Secondary:   Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24   [ Time Frame: Baseline, Week 12 and Week 24 ]

4.  Secondary:   Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24   [ Time Frame: Baseline, Week 12 and Week 24 ]

5.  Secondary:   Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Weeks 12 and 24   [ Time Frame: Baseline, Week 12 and Week 24 ]

6.  Secondary:   Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Particular Event   [ Time Frame: Baseline up to Week 24 ]

7.  Secondary:   Number of Participants With Any Adverse Events, Any Serious Adverse Events and Adverse Events Leading to Discontinuation   [ Time Frame: From the start of study treatment up to Week 24 ]

8.  Secondary:   Number of Participants With Physical Examination Findings   [ Time Frame: Baseline, Week 12 and Week 24 ]

9.  Secondary:   Change From Baseline in Electrocardiogram (ECG) Heart Rate Values at Weeks 12 and 24   [ Time Frame: Baseline, Week 12 and Week 24 ]

10.  Secondary:   Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Interval Corrected Bazett's Formula (QTcB) Values at Weeks 12 and 24   [ Time Frame: Baseline, Week 12 and Week 24 ]

11.  Secondary:   Change From Baseline in Systolic and Diastolic Blood Pressure at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

12.  Secondary:   Change From Baseline in Heart Rate at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

13.  Secondary:   Oral Temperature   [ Time Frame: Baseline ]

14.  Secondary:   Number of Participants With Shift From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) and Total Bilirubin (BILT) up to Week 24   [ Time Frame: Baseline up to Week 24 ]

15.  Secondary:   Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

16.  Secondary:   Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

17.  Secondary:   Change From Baseline in Hematocrit at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

18.  Secondary:   Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

19.  Secondary:   Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

20.  Secondary:   Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

21.  Secondary:   Change From Baseline in Albumin, Globulin and Total Protein at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

22.  Secondary:   Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

23.  Secondary:   Mean Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

24.  Secondary:   Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 24   [ Time Frame: Baseline up to Week 24 ]

25.  Secondary:   Number of Participants With Urinalysis Data at Baseline and Week 24   [ Time Frame: Baseline and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01808313     History of Changes
Other Study ID Numbers: 115812
Study First Received: February 28, 2013
Results First Received: April 2, 2015
Last Updated: April 27, 2015
Health Authority: China: Food and Drug Administration