Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000357550
Ethics application status
Approved
Date submitted
8/02/2015
Date registered
20/04/2015
Date last updated
20/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of micro encapsulated highly bioavailable Simvastatin on plasma lipid profile and oxidative status in patients with high plasma cholesterol level
Scientific title
The effect of micro encapsulated highly bioavailable Simvastatin on plasma lipid profile and oxidative status in patients with high plasma cholesterol level
Secondary ID [1] 286124 0
None
Universal Trial Number (UTN)
U1111-1166-5223
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atherosclerosis 294129 0
hyperlipidemia 294130 0
hypercholesterolemia 294131 0
cardiovascular disease 294463 0
atherosclerosis 294464 0
coronary heart disease 294465 0
Condition category
Condition code
Metabolic and Endocrine 294450 294450 0 0
Metabolic disorders
Cardiovascular 294974 294974 0 0
Coronary heart disease
Alternative and Complementary Medicine 294975 294975 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each volunteer will be given once daily at the evening time 20 mg lycosome-formulated simvastatin fused with 7 mg of lycopene or the same amount (20 mg) of unmodified simvastatin with no lycopene. Control patients will be given 7 mg of lycopene alone. All study products will be given orally for a period of 4 weeks. Adherence to the study protocol will be monitored by questioning of the patients and plasma measurements of simvastatin at the end of interventional period.
Intervention code [1] 291124 0
Treatment: Drugs
Comparator / control treatment
Control patients will be given once a day for a period of 4 weeks oral tablets containing 7 mg of lycopene only. Protocol adherence will be monitored by questioning of patients and plasma measurements of lycopene at the end of interventional period.
Control group
Active

Outcomes
Primary outcome [1] 294239 0
Primary outcome of this clinical trial is to verify an effect of lycosome formulated simvastatin (Lycosimvastatin)on blood lipid profile in patients with hypercholesterolemia as assessed by biochemical measurements of major classes of lipids in serum and plasma using Biosystems Inc. microanalyzer with corresponding analytic kits.

and oxidative status in patients with hypercholesterolemia.
Timepoint [1] 294239 0
End of the 4th week of interventional period
Primary outcome [2] 294524 0
Primary outcome of this clinical trial is to verify an effect of lycosome formulated simvastatin (Lycosimvastatin)on parameters of oxidation in the patients with hypercholesterolemia as assessed by biochemical measurements of malonic dialdehyde levels and activity of superoxide dismutase in blood.
Timepoint [2] 294524 0
End of the 4th week of interventional period
Secondary outcome [1] 312862 0
- Investigation of the effect of Lycosimvastatin on composition of plasma lipid profile (total cholesterol, LDL, HDL, triglycerides) in patients with hypercholesterolemia as assessed by biochemical measurements of major lipid classes in plasma.
Timepoint [1] 312862 0
End of the 2nd and 4th week of interventional period
Secondary outcome [2] 313565 0
Evaluation of the effect of Lycosimvastatin on oxidative status in patients with hypercholesterolemia as assessed by biochemical measurements of malonic dialdehyde and acitivity of superoxide dismutase in plasma.
Timepoint [2] 313565 0
End of the 2nd and 4th weeks of interventional period

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
studies.
(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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Medical personal of outpatient clinic of the Sarartov’s Institute of Cardiology will be informed about launching the trial, its major goals and selection criteria for volunteers. Suitable individuals will be invited for preliminary check-up (physical and laboratory investigation) during the initial phase of enrollment. All suitable individuals will be re-screened after wash-out period of the trail before final decision on trial enrollment is made. Allocation is not concealed in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of volunteers in the trial will be performed using widely accepted methods such as simple randomization and stratified randomization. Briefly, the software containing random number generator will be applied to database of the volunteers. They assigned group will be considered as a final. The groups will be balanced according to numerical age and gender with special software. Stratified randomization will be used to enhance statistical power of the final results and will ensure equality of groups in secondary selection criteria.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the assessment of normally distributed parameters, the Shapiro-Wilk method will be used. Student’s t-test will be then applied both for paired and unpaired samples. In cases where parameters are not normally distributed Mann-Whitney U- test and Kruskal-Wallis test will be used. ANOVA and ANCOVA will be used with post hoc analysis (Statistica 9 suit, StatSoft; Inc.). Statistical significance between two-tailed parameters was considered to be P<0.05. Sample size determination was performed based on the results of pilot clinical trial. It was determined that a minimum number of patients in each group has to be 30 patients. Due to possibility of drop-outs targeted number of patients is set to be 40 patients in each group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/02/2015
Actual
5/02/2015
Date of last participant enrolment
Anticipated
6/05/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 6636 0
United Kingdom
State/province [1] 6636 0
Cambridge
Country [2] 6637 0
Russian Federation
State/province [2] 6637 0
saratov

Funding & Sponsors
Funding source category [1] 290703 0
Commercial sector/Industry
Name [1] 290703 0
Lycotec Ltd
Country [1] 290703 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Lycotec Ltd, Cambridge, UK
Address
Platinum Building, Granta Park Campus, Cambridge, CB21 6GP.
Country
United Kingdom
Secondary sponsor category [1] 289395 0
Charities/Societies/Foundations
Name [1] 289395 0
NUTRA Sp. Z.o.o.
Address [1] 289395 0
Ul. Rydygiera 8 building 3A
01-791 Warsaw, Poland
Country [1] 289395 0
Poland
Other collaborator category [1] 278332 0
Government body
Name [1] 278332 0
Institute of Cardiology
Address [1] 278332 0
12 Chernyshevskogo Str, Saratov, Russia, 410028
Country [1] 278332 0
Russian Federation

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292338 0
Institutional review board, Institute of Cardiology
Ethics committee address [1] 292338 0
12 Chernyshevskogo Str, Saratov, Russia, 410028
Ethics committee country [1] 292338 0
Russian Federation
Date submitted for ethics approval [1] 292338 0
07/01/2015
Approval date [1] 292338 0
26/01/2015
Ethics approval number [1] 292338 0
122-74/32

Summary
Brief summary
Hypercholesterolemia treatment is a challenging task in the modern internal medicine. Diet, exercise and inhibitors of HMG-CoA reductase (statins) inhibitors are among therapeutic options in the hypercholesterolemia. However statins are poorly absorbed in the intestine and have a low bioavailability. Microencapsulation methods are shown to increase intestinal absorption and bioavailability of many drugs. We hypothesize that microencapsulation of statins with lycopene will increase bioavailbility of simvastatin and will enhance its therapeutic effect.
Trial website
Lycotec.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53938 0
Dr Ivan M Petyaev MD, PhD
Address 53938 0
Lycotec Ltd, Granta Park, Cambridge, CB21 6GP, United Kingdom.
Country 53938 0
United Kingdom
Phone 53938 0
Tel (44) -1223-42-721
Fax 53938 0
Fax (44)-1223-42-72.
Email 53938 0
[email protected]
Contact person for public queries
Name 53939 0
Mr Nigel H Kyle
Address 53939 0
Lycotec Ltd, Granta Park, Cambridge, CB21 6GP, United Kingdom.
Country 53939 0
United Kingdom
Phone 53939 0
Tel (44) -1223-42-721
Fax 53939 0
Fax (44)-1223-42-72.
Email 53939 0
[email protected]
Contact person for scientific queries
Name 53940 0
Dr Yuriy K Bashmakov MD, PhD
Address 53940 0
Lycotec Ltd, Granta Park, Cambridge, CB21 6GP, United Kingdom.
Country 53940 0
United Kingdom
Phone 53940 0
Tel (44) -1223-42-721
Fax 53940 0
Fax (44)-1223-42-72.
Email 53940 0
[email protected]

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