Prevenox Plus versus original Prevenox: Comparison of effects in healthy volunteers

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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)

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

Country:

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

Country:

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

Country:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

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

Email:

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:

2025/03/07

Next update date:

2026/03/07

Link to the spanish version:

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Registered Trials

Registration process

Prevenox Plus versus original Prevenox: Comparison of effects in healthy volunteers

About the RPCEC

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