ACTRN12615000357550RecruitingPhase 2
The effect of micro encapsulated highly bioavailable Simvastatin on plasma lipid profile and oxidative status in patients with high plasma cholesterol level
ycotec Ltd, Cambridge, UK0 sites120 target enrollmentStarted: April 20, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •Major inclusion criteria were as follows: Caucasian male or female subjects 40-65 years old, elevated total plasma cholesterol (over 200 mg/dl), elevated plasma LDL (over 150 mg/dl), plasma markers for oxidative stress LDL-Px ELISA ×103 over 250 microM/ml and IOD over 40 microM/mL, absence of concomitant intake of anti-hypertensive, lipid-lowering or any other cardiovascular drugs.
Exclusion Criteria
- •Among exclusion criteria were:
- •(1)Unwillingness to sign informed consent.
- •(2) Unable to comply with the protocol for the duration
- •of the study.
- •(3) History of MI in the 3 months preceding the study.
- •(4) Ejection fraction (EF) higher than 45%.
- •(5) Significant medical condition that would impact
- •safety considerations (e.g., significantly elevated LFT,
- •hepatitis, severe dermatitis, uncontrolled diabetes,
- •cancer, severe GI disease, fibromyalgia, renal failure,
- •recent CVA (cerebrovascular accident), pancreatitis,
- •respiratory diseases, epilepsy, etc.).
- •(6) Compulsive alcohol abuse (more than 10 drinks weekly), or
- •regular exposure to other substances of abuse.
- •(7) Participation in other nutritional or pharmaceutical
- •(8) Resting heart rate of more than 100 beats per minute or less than 45 beats per minute. inability to comply with the study protocol, severe medical conditions (hepatitis, pancreatitis, uncontrolled diabetes, cancer, recent cardiovascular events, tuberculosis etc).
Investigators
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