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Completed

NCT Number: NCT04254042

Comparative Effects of Perindopril and Zofenopril on Blood Pressure Control and Oxidative Status Blacks Hypertensive Patients.

The aim of the study is to compare the short term effect of perindopril and zofenopril in the management of hypertension and the oxydative stress in blacks hypertensive patients.

PEZO-HP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yaounde Central Hospital, Cardiology department

Yaoundé, Cameroon

About this study

Aim: to determine and compare the short term effect of angiotensin converting in the management of hypertension as well as the oxidative effect of Zofenopril and perindopril in blacks hypertensive patients in the Yaoundé Central Hospital.

Method: A double-arm, double-blind, randomized and parallel clinical trial conducted at the Yaoundé Central Hospital. Hypertensive patients who are not taking angiotensin-converting enzyme inhibitor or angiotensin receptors blockers, are randomize into 2 groups. Depending on the group, the intervention consisted of the administration of Perindopril 10 mg daily or Zofenopril 30 mg daily for 08 weeks. The endpoints were the nycthemeral blood pressure profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (Ferric reducing antioxidant).

Progress: Recruitment for PEZO-HP was completed in May 2019 with 24 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypertensive patients
  • On a stable atihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. The pharmacological treatment should not include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker
  • Subject must not present any contraindication to exercise
  • Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion criteria

  • Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
  • Withdrawal of consent

Treatment and study plan

Perindopril Arginine

Drug

10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Other names: Perindopril

Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer

Drug

30 mg Zofenopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Other names: Zofenopril

Primary outcomes

  1. Change in nycthemeral blood pressure profile (mmHg)

    Time frame: 8 weeks

    Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.

Secondary outcomes

  1. Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)

    Time frame: 8 weeks

    Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer

  2. Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol)

    Time frame: 8 weeks

    Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Registry information

Official study title

Rationale and Design of a Simple Randomized Trial Evaluating Comparative Effects of Perindopril and Zofenopril in Blacks Hypertensive Patients: Short Term Effects on Cardiac and Oxidative Status With Perindopril or Zofenopril (PEZO-HP) Trial

Acronym: PEZO-HP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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