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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 1, 2019

Detailed Description

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.

Interventions

  • Drug: Perindopril Arginine
    • 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
  • Drug: Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer
    • 30 mg Zofenopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.

Arms, Groups and Cohorts

  • Active Comparator: Perindopril Arm
    • 10 mg Perindopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.
  • Active Comparator: Zofenopril Arm
    • 30 mg Zofenopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yaounde Central Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: CN NGANOU-GNINDJIO, MD, MSc, Dr, Principal investigator – Yaounde Central Hospital

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