None listed
Conditions
Brief summary
Drugs are originally produced by one pharmaceutical company and are considered to be the perfect comparator products. When the patent expires, other companies can produce a similar product with comparable efficacy and safety. These drugs are called generic drugs. Currently, CADILA Pharmaceuticals Ltd (Ethiopia) produce the Enalapril (Envas) in Ethiopia. However, to ensure its effectiveness, the comparative efficacy and safety of this drug against the original products should be tested.. Currently, appropriate tests (bioequivalence tests) to prove effectiveness are not available in Ethiopia. Many patients with hypertension take Enalapril to control their blood pressure. Using locally produced Enalapril is a cheaper option for patients with hypertension. However, as mentioned above, there is no evidence that proves that locally produced Enalapril works as well as the original (standard) Enalapril. The aim of the trial is to test whether locally produced Enalapril works as well as imported Enalapril in the treatment of hypertension.
Interventions
Drug: Locally produced Enalapril-Envas (Cadila pharmaceutical, Ethiopia)
Dose: 5-20mg. Participants in this study are those whose blood pressure is controlled with Enalapril. Therefore, participants will continue on the dose that they are currently taking for the duration of the trial. For example, if the patient is taking 10mg, she/he will continue taking the same dose. The dose determination and follow up during the study will be made by the treating physician.
Frequency: once daily in the
Drug: Locally produced Enalapril-Envas (Cadila pharmaceutical, Ethiopia) Dose: 5-20mg. Participants in this study are those whose blood pressure is controlled with Enalapril. Therefore, participants will continue on the dose that they are currently taking for the duration of the trial. For example, if the patient is taking 10mg, she/he will continue taking the same dose. The dose determination and follow up during the study will be made by the treating physician. Frequency: once daily in the morning Duration: There are 3 pairs of treatment periods. Each pair of treatment period comprises 1 week of Envas and 1 week of EnaDenk -treatment crossover occurs weekly. Individual patients will take Envas for 3 treatment periods of 1 week each. Mode: Per oral Adherence monitoring : To avoid treatment non-compliance, every week, there will be a drug adherence counselling session by the study nurse before drug dispensing. Moreover, every week, the study nurse will check pill boxes and ask questions if there are missed medications. Washout period: Participants will move straight on from treatment period 1 to treatment period 2 on consecutive days. To account for washout from the previous period, the first two days of BP readings in each treatment period will be discarded i.e. two days analytical washout period.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Outcome results
None listed