Trial Outcomes & Findings for Anastrozole in Patients With Pulmonary Arterial Hypertension (NCT NCT01545336)
NCT ID: NCT01545336
Last Updated: 2016-10-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2016-10-27
Participant Flow
Participant milestones
| Measure |
Anastrozole
Anastrozole 1 mg tablet by mouth once daily for 3 months
|
Placebo
Placebo 1 mg tablet by mouth once daily for 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anastrozole in Patients With Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Anastrozole
n=12 Participants
Anastrozole 1 mg tablet by mouth once daily for 3 months
|
Placebo
n=6 Participants
Placebo 1 mg tablet by mouth once daily for 3 months
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 13 • n=5 Participants
|
59 years
STANDARD_DEVIATION 10 • n=7 Participants
|
60.06 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Six minute walk distance
|
336 meters
STANDARD_DEVIATION 119 • n=5 Participants
|
378 meters
STANDARD_DEVIATION 161 • n=7 Participants
|
350 meters
STANDARD_DEVIATION 131 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsOutcome measures
| Measure |
Anastrozole
n=12 Participants
1 mg tablet by mouth once daily for 3 months
Anastrozole: 1 mg tablet to be taken 1 time daily
|
Placebo
n=6 Participants
Placebo tablet by mouth once daily for 3 months
Placebo: 1 mg tablet to be taken 1 time daily
|
|---|---|---|
|
Plasma Estradiol (E2) Level
|
-40 % change from baseline
Interval -61.0 to -26.0
|
-4 % change from baseline
Interval -14.0 to 4.0
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsOutcome measures
| Measure |
Anastrozole
n=12 Participants
1 mg tablet by mouth once daily for 3 months
Anastrozole: 1 mg tablet to be taken 1 time daily
|
Placebo
n=6 Participants
Placebo tablet by mouth once daily for 3 months
Placebo: 1 mg tablet to be taken 1 time daily
|
|---|---|---|
|
Tricuspid Annular Plane Systolic Excursion (TAPSE)
|
7 % change from baseline
Interval 0.0 to 28.0
|
10 % change from baseline
Interval -6.0 to 33.0
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsOutcome measures
| Measure |
Anastrozole
n=12 Participants
1 mg tablet by mouth once daily for 3 months
Anastrozole: 1 mg tablet to be taken 1 time daily
|
Placebo
n=6 Participants
Placebo tablet by mouth once daily for 3 months
Placebo: 1 mg tablet to be taken 1 time daily
|
|---|---|---|
|
Six Minute Walk Distance
|
8 % change from baseline
Interval 2.0 to 17.0
|
-2 % change from baseline
Interval -7.0 to 1.0
|
Adverse Events
Anastrozole
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anastrozole
n=12 participants at risk
Anastrozole 1 mg tablet by mouth once daily for 3 months
|
Placebo
n=6 participants at risk
Placebo 1 mg tablet by mouth once daily for 3 months
|
|---|---|---|
|
Gastrointestinal disorders
Hemorrhoid: lower gastrointestinal bleed
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
Other adverse events
| Measure |
Anastrozole
n=12 participants at risk
Anastrozole 1 mg tablet by mouth once daily for 3 months
|
Placebo
n=6 participants at risk
Placebo 1 mg tablet by mouth once daily for 3 months
|
|---|---|---|
|
General disorders
Myalgias
|
33.3%
4/12 • Number of events 4 • Adverse event data collected from Screening through 3 months
|
33.3%
2/6 • Number of events 2 • Adverse event data collected from Screening through 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Fever
|
16.7%
2/12 • Number of events 2 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
Gastrointestinal disorders
Abdominal distention
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Anorexia
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
16.7%
1/6 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Confusion
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
33.3%
2/6 • Number of events 2 • Adverse event data collected from Screening through 3 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Headache
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
33.3%
2/6 • Number of events 2 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Jaw pain
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
16.7%
1/6 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Oral thrush
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Side cramps
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
Ear and labyrinth disorders
Sinus congestion
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Weight loss
|
8.3%
1/12 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
0.00%
0/6 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Hot flashes
|
0.00%
0/12 • Adverse event data collected from Screening through 3 months
|
16.7%
1/6 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Lightheadedness
|
0.00%
0/12 • Adverse event data collected from Screening through 3 months
|
16.7%
1/6 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Night sweats
|
0.00%
0/12 • Adverse event data collected from Screening through 3 months
|
16.7%
1/6 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Adverse event data collected from Screening through 3 months
|
16.7%
1/6 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
|
General disorders
Presyncope
|
0.00%
0/12 • Adverse event data collected from Screening through 3 months
|
16.7%
1/6 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
|
Musculoskeletal and connective tissue disorders
Worsening Raynaud's disease
|
0.00%
0/12 • Adverse event data collected from Screening through 3 months
|
16.7%
1/6 • Number of events 1 • Adverse event data collected from Screening through 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place