Darusentan Effect on PET Uptake Heterogeneity

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronary Artery Disease, Endothelial Dysfunction

In brief

The primary objective of this study is to test the hypothesis that myocardial perfusion heterogeneity, quantified by Markovian Homogeneity analysis of cardiac PET perfusion images, will improve in a quantitative manner after treatment with selective ETA receptor antagonist darusentan 100 mg per day for 2 weeks compared to baseline and post-treatment PET scans in clinically stable subjects with coronary atherosclerosis and/or risk factors.

Key facts

Study ID

NCT00738049

Run by

K.Lance Gould

People needed

40

Starts

2009-06-01

Expected to finish

2011-08-01

Last updated by the study team

2014-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be competent to provide written informed consent. Subjects must sign an IRB approved ICF and HIPAA Authorization prior to the initiation of any study procedures. All men must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking study drug, and queried regarding their understanding of the potential risks as described in the ICF.
• Subjects must be greater than 18 years of age.
• Female subjects must be surgically sterile or documented as post-menopausal for at least 2 years.
• Subjects must have documented coronary artery disease as evidenced by previous myocardial infarction, interventional procedure, significant stenosis by cardiac catheterization, or an abnormal perfusion study.
• Subjects must have an abnormal PET scan.

You may not qualify if…

• Subjects with acute heart failure
• Subjects with sustained or symptomatic hypotension (SBP 90 mmHg)
• Subjects with uncontrolled hypertension (SBP of 170 mmHg or DBP of 100 mmHg) at Screening
• Subjects with unstable angina pectoris
• Subjects with acute myocardial infarction, stroke, transient ischemic attack, or coronary angioplasty within the last 6 months
• Subjects with primary valvular disease
• Subjects with significant vascular aneurysm
• Subjects with a documented history of renal failure
• Subjects with liver disease (total bilirubin 3 mg/dL or serum ALT or AST >2X ULN)
• Subjects with active malignancy
• Subjects with a fatal non-cardiovascular disease that they are expected to succumb to within 1 year
• Female subjects that are pregnant or lactating
• Female subjects with the potential for child-bearing
• Female subjects being treated with hormone therapies
• Subjects with uncontrolled diabetes mellitus
• Subjects with diabetes with gastro paresis or severe neuropathy
• Subjects with a history of substance abuse within the last 2 years
• Subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the Screening Visit
• Subjects with known hypersensitivity or allergy to L-arginine, aminophylline, adenosine, or dipyridamole
• Subjects who have a planned surgical procedure during the course of the study
• Subjects taking herbal food supplements (L-carnitine, L-arginine or Ginko biloba)
• Subjects with known active or dormant type 2 herpes simplex virus infections
• Subjects with a contraindication to treatment with an ERA. Contraindications may include, but are not limited to, evidence of elevated liver function tests (e.g., aminotransferases >2X ULN) or an event defined as a serious adverse event attributed to previous treatment with an ERA
• Subjects who are judged by the investigator to be ineligible for this study for any other reason

Where it is running

• Weatherhead PET Center for Preventing and Reversing Atherosclerosis, UT Medical School, Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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