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Pulmonary Hypertension and Anastrozole Trial

NCT03229499 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-05-01

Study results available
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Summary

The primary objectives of this study are to determine whether the study drug, anastrozole may improve six minute walk distance at six months compared to placebo and to assess safety and side effects up to twelve months in pulmonary arterial hypertension (PAH).

Conditions

Interventions

DRUG

Anastrozole

Anastrozole is an aromatase inhibitor indicated for: * adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer * first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer * treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.

DRUG

Placebo Oral Tablet

matching placebo tablet

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Johns Hopkins University

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Rhode Island Hospital

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Vanderbilt University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Steven M Kawut, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2022-07-22
Completion
2022-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03229499 on ClinicalTrials.gov