Status:
COMPLETED
Darusentan Effect on PET Uptake Heterogeneity
Lead Sponsor:
K.Lance Gould
Collaborating Sponsors:
Gilead Sciences
Conditions:
Coronary Artery Disease
Endothelial Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 q...
Detailed Description
This 6-week, Phase 2, randomized, double-blind, crossover, investigator-initiated, single-center study will determine the feasibility of detecting the effect of darusentan 100 mg once daily on the ext...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00738049
Start Date
June 1 2009
End Date
August 1 2011
Last Update
August 15 2014
Active Locations (1)
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1
Weatherhead PET Center for Preventing and Reversing Atherosclerosis, UT Medical School, Memorial Hermann Hospital
Houston, Texas, United States, 77030