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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.
 
ClinicalTrials.gov Identifier: NCT01545336
Recruitment Status : Completed
First Posted : March 6, 2012
Results First Posted : August 9, 2016
Last Update Posted : October 27, 2016
Sponsor:
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
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anastrozole Placebo
Hide Arm/Group Description Anastrozole 1 mg tablet by mouth once daily for 3 months Placebo 1 mg tablet by mouth once daily for 3 months
Period Title: Overall Study
Started 12 6
Completed 12 6
Not Completed 0 0
Arm/Group Title Anastrozole Placebo Total
Hide Arm/Group Description Anastrozole 1 mg tablet by mouth once daily for 3 months Placebo 1 mg tablet by mouth once daily for 3 months Total of all reporting groups
Overall Number of Baseline Participants 12 6 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 6 participants 18 participants
61  (13) 59  (10) 60.06  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 18 participants
Female
7
  58.3%
2
  33.3%
9
  50.0%
Male
5
  41.7%
4
  66.7%
9
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 18 participants
Hispanic or Latino
1
   8.3%
0
   0.0%
1
   5.6%
Not Hispanic or Latino
11
  91.7%
6
 100.0%
17
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 6 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  33.3%
0
   0.0%
4
  22.2%
White
8
  66.7%
6
 100.0%
14
  77.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 6 participants 18 participants
12 6 18
Six minute walk distance  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 12 participants 6 participants 18 participants
336  (119) 378  (161) 350  (131)
1.Primary Outcome
Title Plasma Estradiol (E2) Level
Hide Description [Not Specified]
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anastrozole Placebo
Hide Arm/Group Description:

1 mg tablet by mouth once daily for 3 months

Anastrozole: 1 mg tablet to be taken 1 time daily

Placebo tablet by mouth once daily for 3 months

Placebo: 1 mg tablet to be taken 1 time daily

Overall Number of Participants Analyzed 12 6
Median (Inter-Quartile Range)
Unit of Measure: % change from baseline
-40
(-61 to -26)
-4
(-14 to 4)
2.Primary Outcome
Title Tricuspid Annular Plane Systolic Excursion (TAPSE)
Hide Description [Not Specified]
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anastrozole Placebo
Hide Arm/Group Description:
Anastrozole 1 mg tablet by mouth once daily for 3 months
Placebo 1 mg tablet by mouth once daily for 3 months
Overall Number of Participants Analyzed 12 6
Median (Inter-Quartile Range)
Unit of Measure: % change from baseline
7
(0 to 28)
10
(-6 to 33)
3.Secondary Outcome
Title Six Minute Walk Distance
Hide Description [Not Specified]
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anastrozole Placebo
Hide Arm/Group Description:
Anastrozole 1 mg tablet by mouth once daily for 3 months
Placebo 1 mg tablet by mouth once daily for 3 months
Overall Number of Participants Analyzed 12 6
Median (Inter-Quartile Range)
Unit of Measure: % change from baseline
8
(2 to 17)
-2
(-7 to 1)
Time Frame Adverse event data collected from Screening through 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anastrozole Placebo
Hide Arm/Group Description Anastrozole 1 mg tablet by mouth once daily for 3 months Placebo 1 mg tablet by mouth once daily for 3 months
All-Cause Mortality
Anastrozole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Anastrozole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      0/6 (0.00%)    
Gastrointestinal disorders     
Hemorrhoid: lower gastrointestinal bleed   1/12 (8.33%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia   1/12 (8.33%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anastrozole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/12 (33.33%)      2/6 (33.33%)    
Cardiac disorders     
Palpitations   0/12 (0.00%)  0 1/6 (16.67%)  1
Ear and labyrinth disorders     
Sinus congestion   1/12 (8.33%)  1 0/6 (0.00%)  0
Gastrointestinal disorders     
Diarrhea   2/12 (16.67%)  2 0/6 (0.00%)  0
Abdominal distention   1/12 (8.33%)  1 0/6 (0.00%)  0
Gastroenteritis   1/12 (8.33%)  1 0/6 (0.00%)  0
General disorders     
Myalgias   4/12 (33.33%)  4 2/6 (33.33%)  2
Fever   2/12 (16.67%)  2 0/6 (0.00%)  0
Anorexia   1/12 (8.33%)  1 1/6 (16.67%)  1
Confusion   1/12 (8.33%)  1 0/6 (0.00%)  0
Fatigue   1/12 (8.33%)  1 2/6 (33.33%)  2
Headache   1/12 (8.33%)  1 2/6 (33.33%)  2
Insomnia   1/12 (8.33%)  1 0/6 (0.00%)  0
Jaw pain   1/12 (8.33%)  1 1/6 (16.67%)  1
Oral thrush   1/12 (8.33%)  1 0/6 (0.00%)  0
Side cramps   1/12 (8.33%)  1 0/6 (0.00%)  0
Weight loss   1/12 (8.33%)  1 0/6 (0.00%)  0
Hot flashes   0/12 (0.00%)  0 1/6 (16.67%)  1
Lightheadedness   0/12 (0.00%)  0 1/6 (16.67%)  1
Night sweats   0/12 (0.00%)  0 1/6 (16.67%)  1
Presyncope   0/12 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders     
Worsening Raynaud's disease   0/12 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   1/12 (8.33%)  1 0/6 (0.00%)  0
Upper respiratory infection   1/12 (8.33%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
  • Small sample size
  • No changes in echo parameters
  • Unclear mechanism for impact on 6MWD
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
Layout table for Results Point of Contact information
Name/Title: Dr. Steven M. Kawut
Organization: University of Pennsylvania
Phone: 215-573-0258
EMail: kawut@upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01545336    
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