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Anastrozole in Patients With Pulmonary Arterial Hypertension (AIPH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01545336
First received: February 29, 2012
Last updated: August 9, 2016
Last verified: August 2016
Results First Received: June 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Anastrozole
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
Anastrozole Anastrozole 1 mg tablet by mouth once daily for 3 months
Placebo Placebo 1 mg tablet by mouth once daily for 3 months

Participant Flow:   Overall Study
    Anastrozole     Placebo  
STARTED     12     6  
COMPLETED     12     6  
NOT COMPLETED     0     0  



  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
Anastrozole Anastrozole 1 mg tablet by mouth once daily for 3 months
Placebo Placebo 1 mg tablet by mouth once daily for 3 months
Total Total of all reporting groups

Baseline Measures
    Anastrozole     Placebo     Total  
Number of Participants  
[units: participants]
  12     6     18  
Age  
[units: years]
Mean (Standard Deviation)
  61  (13)     59  (10)     60.06  (11.5)  
Gender  
[units: participants]
     
Female     7     2     9  
Male     5     4     9  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     11     6     17  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     0     4  
White     8     6     14  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     12     6     18  
Six minute walk distance  
[units: meters]
Mean (Standard Deviation)
  336  (119)     378  (161)     350  (131)  



  Outcome Measures
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1.  Primary:   Plasma Estradiol (E2) Level   [ Time Frame: Baseline, 3 months ]

2.  Primary:   Tricuspid Annular Plane Systolic Excursion (TAPSE)   [ Time Frame: Baseline, 3 months ]

3.  Secondary:   Six Minute Walk Distance   [ Time Frame: Baseline, 3 months ]


  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
  • Small sample size
  • No changes in echo parameters
  • Unclear mechanism for impact on 6MWD


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Steven M. Kawut
Organization: University of Pennsylvania
phone: 215-573-0258
e-mail: kawut@upenn.edu



Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01545336     History of Changes
Other Study ID Numbers: 815035
Study First Received: February 29, 2012
Results First Received: June 29, 2016
Last Updated: August 9, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration