Hypertension Clinical Trial
— NevibololOfficial title:
The Efficacy and Tolerability of Highly Selective Beta-1 Agent in Hypertensive Black Patients Residing in Sub Saharan Africa: A Pilot Study
NCT number | NCT03598673 |
Other study ID # | UAbuja |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 27, 2018 |
Est. completion date | April 27, 2019 |
Verified date | August 2021 |
Source | University of Abuja |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Although Nebivolol, a highly selective beta-1 agent has been shown to be effective in reducing blood pressure in Blacks, this was in African Americans with no study in Blacks residing in sub Saharan Africa. We therefore decided to study the effectiveness and safety of Nebivolol in Black patients with stage 1 hypertension (systolic BP of 140-149 and/or diastolic BP of 90-99 mmHg) presenting to five primary care centres in Nigeria.
Status | Completed |
Enrollment | 200 |
Est. completion date | April 27, 2019 |
Est. primary completion date | December 27, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 59 Years |
Eligibility | Inclusion Criteria: The patients should be aged 30-59 years with a sitting SBP =140 mm Hg and <160 mmHg and/or DBP = 90 and <100 mmHg on no antihypertensive agent Exclusion Criteria: 1.Those with clinically defined congestive heart failure 2. Those with clinical features of renal failure 3. Those with history of coronary heart disease including chronic stable angina, myocardial infarction or acute coronary syndrome 4. Patients with a history of a stroke or transient ischaemic attack 5. Patients with known or suspected secondary hypertension 6. Those with any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study 7. Those who are pregnant or those of child-bearing age who are not taking reliable contraception. - |
Country | Name | City | State |
---|---|---|---|
Nigeria | Africa International College | Abuja | FCT |
Nigeria | University of Abuja Teaching Hospital | Abuja | Federal Capital Territory |
Lead Sponsor | Collaborator |
---|---|
University of Abuja | Micronova Pharmaceuticals Ind Ltd |
Nigeria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in office blood pressure | The primary outcome measure is change in office BP value from baseline to 2 months | 2 months | |
Secondary | The proportion of patients who achieved blood control | The proportion of patients who achieved BP <140 mmHg systolic and <90 mmHg diastolic in two months. | 2 months | |
Secondary | Proportion of patients with adverse events | The proportion of patients who have adverse events with both doses of Nebivolol respectively | 1 month and 2 months | |
Secondary | Change in metabolic profile | Change in plasma fasting blood sugar and fasting lipid profile over two months. | 2 months | |
Secondary | Proportion of male patients with erectile dysfunction | The proportion of male patients who complain of erectile dysfunction on follow up and end of the study | 1 month and 2 months |
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