Anastrozole in Patients With Pulmonary Arterial Hypertension (AIPH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01545336
First received: February 29, 2012
Last updated: October 16, 2012
Last verified: October 2012

February 29, 2012
October 16, 2012
October 2012
October 2015   (final data collection date for primary outcome measure)
  • To assess the effects of anastrozole vs. placebo on the plasma estradiol (E2)level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To assess the effects of anastrozole vs. placebo on tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01545336 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Anastrozole in Patients With Pulmonary Arterial Hypertension
A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: Anastrozole
    1 mg tablet to be taken 1 time daily
    Other Name: Arimidex
  • Drug: Placebo
    1 mg tablet to be taken 1 time daily
    Other Name: Sugar pill manufactured to mimic Anastrozole 1 mg tablet
  • Experimental: Anastrozole
    1 mg tablet by mouth once daily for 3 months
    Intervention: Drug: Anastrozole
  • Placebo Comparator: Placebo
    Placebo tablet by mouth once daily for 3 months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mamta Patel, RN 215-662-9720 mamta.patel@uphs.upenn.edu
United States
 
NCT01545336
815035
Yes
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Steven M Kawut, MD, MS University of Pennsylvania
University of Pennsylvania
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP