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

Phase 4

• Conditions: Arterial hypertension; Hypertension; Prehypertension

• Registration Number: RPCEC00000377
• Lead Sponsor: ational Center for Scientific Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-30
• Study Completion: 2022-06-01
• Results First Posted: 2022-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
DL-C (mmol/L). Measurement time: Baseline and at the end of the 12 weeks of treatment. <br>Total cholesterol (mmol/L). Measurement time: Baseline and at the end of the 12 weeks of treatment. <br>HDL-C (mmol/L). Measurement time: Baseline and at the end of the 12 weeks of treatment. <br>(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)<br>