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

Hypertension Clinical Trial

— PEZO-HP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254042
• Other study ID #: PEZO-HP study
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: January 2020
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Cameroon	Yaounde Central Hospital, Cardiology department	Yaounde

Sponsors (1)

Lead Sponsor	Collaborator
Yaounde Central Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nycthemeral blood pressure profile (mmHg)	Change in nycthemeral blood pressure profile from baseline to week 08. By using Arterial Blood Pressure Monitoring.	8 weeks
Secondary	Change in serum concentration of oxidant marker: malondialdehyde (micromol/l)	Change in concentration of oxidant marker from baseline to week 8. By spectrophotometer	8 weeks
Secondary	Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol)	Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer	8 weeks