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Anastrozole in Patients With Pulmonary Arterial Hypertension

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: Anastrozole (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Steven M Kawut, MD, MS, Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Mamta Patel, RN, Phone: 215-662-9720, Email: mamta.patel@uphs.upenn.edu

Summary

The main purpose of this clinical trial is to study the safety and efficacy of anastrozole in adults diagnosed with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated. The study will also evaluate if anastrozole effects estradiol (E2) hormone levels, a sex hormone, and improves the function of the lower right chamber of the heart (right ventricle).

Clinical Details

Official title: A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

To assess the effects of anastrozole vs. placebo on the plasma estradiol (E2)level

To assess the effects of anastrozole vs. placebo on tricuspid annular plane systolic excursion (TAPSE)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Previous documentation of mean pulmonary artery pressure > 25 mm Hg with a pulmonary

capillary wedge pressure (or left ventricular end-diastolic pressure) < 16 mm Hg and PVR > 3 WU at any time before study entry.

- Diagnosis of PAH which is idiopathic, heritable, drug- or toxin-induced, or

associated with connective tissue disease, congenital heart disease, portal hypertension, or HIV infection.

- Most recent pulmonary function tests with FEV1/FVC >50% AND either a) total lung

capacity > 70% predicted or b) total lung capacity between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest

- Ability to perform six minute walk testing without limitations in musculoskeletal

function or coordination.

- If female, post-menopausal state, defined as:

- > 50 years old AND

- a) have not menstruated during the preceding 12 months OR

- b) have follicle-stimulating hormone (FSH) levels (> 40 IU/L) OR

- < 50 years and FSH (> 40 IU/L) OR

- having had a bilateral oophorectomy

- Informed consent

Exclusion Criteria:

- Treatment with estrogen or anti-hormone therapy (tamoxifen, fulvestrant, etc.)

- WHO Class IV functional status

- History of breast cancer

- Clinically significant untreated sleep apnea

- Left-sided valvular disease (more than moderate mitral valve stenosis or

insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction < 45% on echocardiography

- Initiation of PAH therapy (prostacyclin analogues, endothelin-1 receptor antagonists,

phosphodiesterase-5 inhibitors) within three months of enrollment; the dose must be stable for at least 3 months prior to Baseline Visit

- Hormone therapy

- Hospitalized or acutely ill

- Renal failure (creatinine > 2. 0)

- Child-Pugh Class C cirrhosis

- Current or recent (< 6 months) chronic heavy alcohol consumption

- Current use of another investigational drug (non-FDA approved) for PAH

- Enrollment in a clinical trial within one month of screening

- Age < 18

Locations and Contacts

Mamta Patel, RN, Phone: 215-662-9720, Email: mamta.patel@uphs.upenn.edu

University of Pennsylvania - Penn Presbyterian, Philadelphia, Pennsylvania 19104, United States; Recruiting
Mamta Patel, RN, Phone: 215-662-9720, Email: mamta.patel@uphs.upenn.edu
Steven M Kawut, MD, MS, Principal Investigator

University of Pennsylvania - Perelman Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Mamta Patel, RN, Phone: 215-662-9720, Email: mamta.patel@uphs.upenn.edu

Brown University - Rhode Island Hospital, Providence, Rhode Island 02903, United States; Not yet recruiting
Amy Palmisciano, RN, BSN, Phone: 401-444-4961, Email: apalmisciano@lifespan.org
Corey Ventetuolo, MD, MS, Principal Investigator

Additional Information

Starting date: October 2012
Last updated: August 4, 2014

Page last updated: November 27, 2014

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