Policosanol in patients with pre-hypertension or with grade I hypertension

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:

PoliHTA

Scientific title:

Effects of policosanol on blood pressure values and lipid profile in patients with pre-hypertension or with grade I hypertension.

Acronym of Scientific Title:

PoliHTA-01

Secondary indentifying numbers:

Poli/P-HTA01

Issuing authority of the secondary identifying numbers:

National Center for Scientific Research

Source(s) of monetary or material support:

National Centre for Scientific Research, Central Account for BioCubafarma

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Moura

Last name:

Revueltas Aguero

Medical Specialty :

Specialist in Integral General Medicine and Hygiene and Epidemiology

Affiliation:

National Institute of Hygiene Epidemiology and Microbiology (INHEM).

Postal address:

Infanta 1158 between Llinas and Clavel

City:

La Habana

País:

Cuba

Zip Code:

10300

Telephone:

+53-54982144

Email address:

moura@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:

Havana, Moncada Polyclinic , Martha Beatriz Diaz Dihesa MD, Specialist in Integral General Medicine

Havana, Rampa Polyclinic, Raciel Vazquez Areco MD, Specialist in Integral General Medicine

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/09/2021

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:

Arterial hypertension

Health condition(s) code:

Hypertension

Prehypertension

Intervention(s):

Two stratum and two experimental group, total of group: 4 Stratum 1 (200 patients with pre-hypertension) Experimental Group 1 (100 patients), Policosanol (20 mg/d): 1 policosanol tablet (20 mg) taken only once a day, oral way, during dinner, for 12 weeks. Control Group 2 (100 patients), Placebo: 1 placebo tablet, which will be taken only once a day, oral way, during dinner, for 12 weeks. Stage 2 (200 patients with grade I hypertension) Experimental Group 1 (100 patients), Policosanol (20 mg/d): 1 policosanol tablet (20 mg) taken only once a day, oral way, during dinner, for 12 weeks. Control Group 2 (100 patients), Placebo: 1 placebo tablet, which will be taken only once a day, oral way, during dinner, for 12 weeks.

Intervention code:

Hypolipidemic Agents

Placebos

Tablets

Administration, Oral

Intervention keyword:

Policosanol, Ateromixol, PPG

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):

Systolic blood pressure (mm Hg). Measurement time: Baseline, 4, 8 and at the end of the 12 weeks of treatment. Diastolic blood pressure (mm Hg). Measurement time: Baseline, 4, 8 and at the end of the 12 weeks of treatment. (Obtain a significant reduction in systolic and / or diastolic blood pressure values with respect to baseline and the placebo group)

Key secondary outcomes:

LDL-C (mmol/L). Measurement time: Baseline and at the end of the 12 weeks of treatment. Total cholesterol (mmol/L). Measurement time: Baseline and at the end of the 12 weeks of treatment. HDL-C (mmol/L). Measurement time: Baseline and at the end of the 12 weeks of treatment. (Obtain a significant reduction in LDL-C and total cholesterol levels, as well as a significant increase in HDL-C, compared to the initial values and to the placebo)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

30 years

Maximum age:

59 years

Inclusion criteria:

1) Patients with pre-hypertension (SBP: 120-139, DBP: 80-89 mmHg), 2) Patients with grade I hypertension (SBP: 140-159, DBP: 90-99 mmHg), 3) With one or two cardiovascular risk factors, 4) Without previous antihypertensive treatment, 5) Of both sexes, 6) Aged between 30 and 59 years, 7) Without a history of diagnosed vascular diseases, 8) Who agreed to participate in the study, signing your informed consent.

Exclusion criteria:

Patients with: 1) Grade II hypertension (SBP: 160-179, DBP: 100-109 mmHg) 2) Grade III hypertension (SBP: 180 and more, DBP: 110 mmHg and more). 3) Isolated systolic hypertension (SBP: 140 and more, DBP less than 90 mmHg). 4) Vascular diseases (coronary, cerebrovascular, peripheral) diagnosed. 5) Diagnosed neoplasms. 6) Diseases or use of medications that could affect blood pressure: endocrinopathies, use of glucorticoids, malabsorption, psychotropic drugs, etc. 7) Any other special condition that at the discretion of the doctor puts your health and life at risk during the study.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

4

Target sample size:

400 patients

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:

Moura

Last Name:

Revueltas Aguero

Specialty:

Specialist in Integral General Medicine and Hygiene and Epidemiology

Affiliation:

National Institute of Hygiene Epidemiology and Microbiology (INHEM).

Postal Address:

Infanta 1158 between Llinas and Clavel

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-54982144

Email :

moura@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:

Ph.D. in Pharmaceutical Sciences

Affiliation:

Clinical Trials Unit, National Center for Scientific Research

Postal Address:

Avenue 25 and 158, Cubanacan, Playa

City:

Havana

País:

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:

National Institute of Hygiene Epidemiology and Microbiology

Status of evaluation:

In review

Status of evaluation date of Ethic Committee:

01/03/2021

Postal address of Ethic Committee :

Infanta 1158 between Llinas y Clavel, Centro Habana, Havana ZC 10300, Cuba

Telephone:

+53-78785919

Correo electrónico:

dirinhem@inhem.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/03/2022

Date of available results:

01/06/2022

Date of first publication:

01/08/2022

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:

RPCEC00000377

Date of Registration in Primary Registry:

30/06/2021

Record Verification Date:

2021/08/31

Next update date:

2022/08/31

Link to the spanish version:

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Policosanol in patients with pre-hypertension or with grade I hypertension

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