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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perindopril Arginine | Drug | 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in serum concentration of anti-oxidant markers: Ferric reducing antioxidant Power (micromol) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yaounde Central Hospital, Cardiology department | Yaoundé | Cameroon |
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PEZO-HP trial is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
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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.
| 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. |
|
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Change in concentration of anti oxidant marker from baseline to week 8. By spectrophotometer |
| 8 weeks |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000608172 | Viacoram |
| D020913 | Perindopril |
| C044958 | zofenopril |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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