Does locally produced Enalapril (Envas) work as well as imported Enalapril (EnaDenk) in the treatment of individual patients with hypertension? Addis Ababa, Ethiopia

Phase 4

• Conditions: Hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12616001088437
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Male and female patients with primary hypertension controlled on Enalapril/Enalapril containing regimen- those who have achieved a blood pressure target of 140/90 mmHg or less in at least the last 2 months (clinic readings)
2. Subjects who are between 18 – 80 years of age
3. Serum electrolytes and creatinine within the normal range (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
4. Normal ECG or stable abnormalities which the clinical investigator does not consider a disqualification for participation in the study
5. Willingness to undergo a pre-study physical examination and laboratory investigations
6. Ability to comprehend and willingness to sign statement of informed consent
7. Women of child bearing potential having effective contraception in place. If this is oral contraception, then they should have been on it at least 2 months.

Exclusion Criteria

1. Any evidence of clinically significant, poorly controlled hematologic, renal, hepatic, or gastrointestinal problems (current thrombocytopenia (platelet count < 100 ×109/L or hemoglobin < 10 g/dL); liver function test abnormalities (alanine aminotransferase or aspartate aminotransferase greater than or equal to' upper limit of normal [ULN]) or severe renal dysfunction (creatinine clearance < 25 mL/min)
2. Any evidence within the last six months of clinically significant diseases involving the cerebrovascular, autoimmune, or cardiovascular systems, including poorly controlled angina pectoris, secondary hypertension, congestive heart failure, or myocardial infarction or stroke.
3. Concomitant use of major psychotropic agents or antidepressant drugs or regular use of nonsteroidal anti-inflammatory agents, high-dose aspirin, or any agent that could raise or lower blood pressure within the last 2 months.
4. A history of drug or alcohol abuse.
5. Sensitivity to angiotensin-converting enzyme (ACE) inhibitors,
6. Unwillingness to follow the study protocol or study-related procedures (e.g. swallow tablets).
7. Clinically significant abnormal ECG findings or vital signs during screening.
8. Clinically significant illness or surgery within 4 weeks prior to study.
9. Pregnant (positive pregnancy test) or breast-feeding women or women who are planning to be pregnant during the trial period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: Mean home Systolic BP difference <br>Outcome assessment: Individual participants will record their blood pressure two times (morning and evening) daily using BP recording diary. <br>BP will be measured using automated BP monitoring devise. [This is a therapeutic equivalence trial designed to assess interchangeablity of two Enalapril formulations. Outcome will be assessed using home blood pressure readings which are taken twice daily (morning and evening) for each of the 3 (2x 1 week) treatment cycles. Outcome will be assessed 6 weeks after intervention commencement. Interchangeablity will be established if equivalence is evident in at least in two cycles out of three.]