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Prevenox Plus versus original Prevenox: Comparison of effects in healthy volunteers
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7 Marzo 2025 - 1:40pm
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13 Diciembre 2025 - 12:20pm
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Prevenox Plus versus original Prevenox: Comparison of effects in healthy volunteers
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
PrevP
Scientific title:
Prevenox Plus versus original Prevenox: Comparison of effects in healthy volunteers
Acronym of Scientific Title:
PrevP/Prev
Secondary indentifying numbers:
PrevP/Prev-01
Issuing authority of the secondary identifying numbers:
National Center for Scientific Research (CNIC)
Primary sponsor:
National Center for Scientific Research (CNIC)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Ministry of Sciencie, Technology and Enviroment (CITMA)
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Ivan
Last name:
Rodriguez Cortina
Medical Specialty :
First Degree Specialist in Internal Medicine
Affiliation:
Medical-Surgical Research Center (CIMEQ)
Postal address:
216 street and 11B, Siboney
City:
Havana
País:
Cuba
Zip Code:
12100
Telephone:
+53-52854146
Email address:
ivan.rodriguez@infomed.sld.cu
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Pending
Date of first enrollment:
27/03/2025
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Healthy volunteers
Intervention(s):
Group 1 Prevenox Plus (Experimental): Prevenox Plus (5 mg), 1 tablet by oral route, twice a day (lunch and dinner), for 12 weeks. Group 2 Prevenox (Experimental): Prevenox (5 mg), 1 tablet by oral route, twice daily (lunch and dinner), for 12 weeks. Group 3 Placebo (Control): Placebo, 1 tablet by oral route, twice a day (lunch and dinner), for 12 weeks.
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
LDL.C. Measurement time: At baseline and 12 weeks of treatment
Key secondary outcomes:
Secondary response variables: 1. Total cholesterol. Measurement time: At baseline and 12 weeks of treatment 2. HDL-C. Measurement time: At baseline and 12 weeks of treatment 3. Tryglicerides. Measurement time: At baseline and 12 weeks of treatment Collateral response variables: 1. Coagulation time. Measurement time: At baseline and 12 weeks of treatment 2. Bleeding time. Measurement time: At baseline and 12 weeks of treatment 3. Prothrombin time. Measurement time: At baseline and 12 weeks of treatment
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
20 years
Maximum age:
60 years
Inclusion criteria:
Healthy subjects of both sexes, aged between 20 and 60 years, who agree to participate in the study after signing their informed consent will be recruited into the study.
Exclusion criteria:
Subjects with: 1. Dyslipidemia 2. High blood pressure 3. Diabetes mellitus 4. Thyroid disorders. 5. History of vascular diseases (coronary, cerebrovascular, peripheral) 6. Major surgery in the six months prior to the start of the study. 7. History of liver or kidney failure. 8. Diagnosed neoplasms. 9. Alcoholism. 10. Consumption of policosanol or another lipid-lowering agent in a period of six months prior to the study. 11. Psychiatric problems that limit their participation. 12. Usual medical history of allergy to medications or any other special condition that, in the doctor's opinion, puts your health and life at risk during the study.
Type of population:
Adults
Type of participant:
Healthy volunteers
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Prevention
Allocation:
Randomized controlled trial
Masking:
Double Blind
Control group:
Placebo
Study design:
Parallel
Phase:
Not entered
Target sample size:
90
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Ivan
Last Name:
Rodriguez Cortina
Specialty:
First Degree Specialist in Internal Medicine
Affiliation:
Medical-Surgical Research Center (CIMEQ)
Postal Address:
216 street and 11 B, Siboney, Playa
City:
Havana
País:
Cuba
Zip Code:
12100
Telephone:
+53-52854146
Email :
ivan.rodriguez@infomed.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Julio
Middle Name:
Cesar
Last Name:
Fernandez Travieso
Specialty:
Doctor in Pharmaceutical Sciencies
Affiliation:
National Center for Scientific Research (CNIC)
Postal Address:
25 avenue and 158 street, Cubanacan, Playa
City:
Havana
País:
Cuba
Zip Code:
11300
Telephone:
+53-59958136
Email :
julio.fernandez@cnic.cu
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
Research Ethics Committees
Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Medical-Surgical Research Center (CIMEQ)
Status of evaluation:
Approved
Status of evaluation date of Ethic Committee:
20/02/2025
Postal address of Ethic Committee :
Calle 216 y 11 B Siboney Playa ZC 12100, Havana, Cuba
Telephone:
+53-72718424
Correo electrónico:
bcimeq@infomed.sld.cu
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
90
Study completion date:
28/08/2025
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000456
Date of Registration in Primary Registry:
07/03/2025
Record Verification Date:
2025/12/13
Next update date:
2026/12/13
Link to the spanish version:
Click here
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