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

Effects of policosanol on blood pressure values and lipid profile in patients with pre-hypertension or with grade I hypertension. - PoliHTA-01

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000377
Enrollment
Unknown
Registered
2021-06-30
Start date
2021-09-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial hypertension

Interventions

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
Placebos
Tablets
Administration, Oral
Policosanol, Ateromixol, PPG

Sponsors

National Center for Scientific Research
Lead Sponsor
OSDE BioCubaFarma
Collaborator

Eligibility

Sex/Gender
All
Age
30 Years to 59 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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)

Countries

Cuba

Contacts

Public ContactMoura Revueltas Aguero

National Institute of Hygiene Epidemiology and Microbiology (INHEM).

moura@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026