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

NCT04254042 | Completed Phase 4 DMC

• 1 other identifier: PEZO-HP study
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Angiotensin Converting Enzymes Inhibitor; Angiotensin II Receptor Blockers; Blood pressure; Oxidative status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  8 weeks

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

  8 weeks

Study Arms (2)

Perindopril Arm

ACTIVE COMPARATOR

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.

Drug: Perindopril Arginine

Zofenopril Arm

ACTIVE COMPARATOR

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.

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

Interventions

Perindopril Arginine DRUG

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

Also known as: Perindopril

Perindopril Arm

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.

Also known as: Zofenopril

Zofenopril Arm

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yaounde Central Hospital: lead

Study Sites (1)

Yaounde Central Hospital, Cardiology department

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Hypertension

Interventions

Viacoram; Perindopril; zofenopril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The double-blind model is applied to the study. Only the adjudicator, responsible for the distribution of medication knew the different regimes. Perindopril and Zofenopril were packaged in boxes of identical appearance and labeled for each participant by name and number of the randomization program. The randomization and packaging of the drugs was done by an investigator who had no clinical involvement.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Principal investigator

Model Details: PEZO-HP trial is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: October 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

CA (1)