Anastrozole in Patients With Pulmonary Arterial Hypertension (AIPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01545336
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : August 9, 2016
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):
University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Interventions: Drug: Anastrozole
Drug: Placebo

  Participant Flow

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
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 

  Baseline Characteristics

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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 12   6   18 
[Units: Years]
Mean (Standard Deviation)
 61  (13)   59  (10)   60.06  (11.5) 
[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

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

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

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

Publications of Results:

Responsible Party: University of Pennsylvania Identifier: NCT01545336     History of Changes
Other Study ID Numbers: 815035
First Submitted: February 29, 2012
First Posted: March 6, 2012
Results First Submitted: June 29, 2016
Results First Posted: August 9, 2016
Last Update Posted: October 27, 2016