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Tamoxifen for Pulmonary Arterial Hypertension

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pulmonary Arterial Hypertension+14 MoreTamoxifen - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether tamoxifen is a safe and effective treatment for pulmonary arterial hypertension. TAPSE and other measures will be used to determine efficacy.

Eligible Conditions
  • Pulmonary Arterial Hypertension
  • Familial Primary Pulmonary Hypertension
  • Primary Pulmonary Hypertension
  • Tamoxifen
  • Estrogen Receptor Antagonists
  • High Blood Pressure
  • Lung Disease
  • Hormone Antagonists
  • Estrogen

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
AV-101
1
Autologous EPCs transfected with human eNOS
1
low dose AV-101

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 24 weeks

24 weeks
HgbA1c
Plasma BNP
Quality of life will be assessed using emPHasis-10 questionnaire. This will be administered at baseline and 12 and 24 weeks.
Quality of life will be assessed using the SF36 questionnaire. This will be administered at baseline and 12 and 24 weeks.
Six minute walk test distance (6MWTD)
Transthoracic echocardiogram (ECHO)-based change in the Tricuspid Annular Plane Systolic Excursion (TAPSE) measurement

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
AV-101
2
Autologous EPCs transfected with human eNOS
2
low dose AV-101

Trial Design

2 Treatment Groups

Tamoxifen
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

24 Total Participants · 2 Treatment Groups

Primary Treatment: Tamoxifen · Has Placebo Group · Phase 2

Tamoxifen
Drug
Experimental Group · 1 Intervention: Tamoxifen · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
772 Previous Clinical Trials
600,380 Total Patients Enrolled
9 Trials studying Pulmonary Arterial Hypertension
2,489 Patients Enrolled for Pulmonary Arterial Hypertension

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The subject can walk for six minutes without difficulty, covering a distance of at least 150 meters and no more than 550 meters.
The patient's status with the World Health Organization is Class I, II, or III.
You must be at least 18 years old to use this service.
People with a documented mean pulmonary artery pressure of 25 mm Hg or more, and a lower pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) of 15 mm Hg or less, and a pulmonary vascular resistance of 3 WU or more, are classified as having Group 1 PAH, according to accepted international classification.
The diagnosis for PAH is idiopathic, meaning that the cause is unknown, heritable, meaning that it is passed down in families, drug- or toxin-induced, or associated with connective tissue disease.
References

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