Status:
TERMINATED
Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients
Lead Sponsor:
Johns Hopkins University
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by their actions ...
Detailed Description
INTRODUCTION BACKGROUND: In recent years, the need to achieve increasingly ambitious therapeutic goals for dyslipidemias has prompted the search for more potent pharmacological agents to lower circul...
Eligibility Criteria
Inclusion
- Patients are eligible for study entry based on the following criteria:
- Males or females greater than or equal to 18 years of age
- Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception.
- LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III criteria
- Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of \< 100 mg/dL
- Baseline lipid criteria: LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL
- Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone \[TSH\])
- Hemoglobin A1C \< 8.5% on a stable oral hypoglycemic or insulin regimen
- On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable.
- Able to give informed consent
Exclusion
- Pre-Randomization Exclusion Criteria
- Patients will not be eligible for the study based on the following criteria:
- History of thyroid disorders of any form within 24 weeks prior to study entry
- Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal
- Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis
- Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry
- Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV)
- Drug or alcohol dependence, or other conditions which may affect study compliance
- Renal insufficiency (serum creatinine \> 2 mg/dL)
- Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones
- Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry
- History of coagulopathy or use of anticoagulants such as warfarin
- Unstable endocrine/metabolic syndrome that may affect lipid metabolism
- History of atrial or ventricular arrhythmia
- Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00311987
Start Date
April 1 2006
End Date
April 1 2007
Last Update
April 2 2013
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224