To Determine the Effect of Nebivolol on Office Blood Pressure of Blacks Residing in Nigeria (Nevibolol)

The Efficacy and Tolerability of Highly Selective Beta-1 Agent in Hypertensive Black Patients Residing in Sub Saharan Africa: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: The Efficacy and Tolerability of Nebivolol in Nigerians

Detailed Description

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. It might be argued that findings in African-Americans can be extrapolated to Black Africans since they have the same ancestral origin, the differences in selection in previous generations, ethnic admixture and differences in lifestyle suggest that such an extrapolation may be inappropriate. We are therefore studying 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 primary care centres in Nigeria.

We hypothesise based on previous findings of the effect of Nebivolol on blood control of African Americans, we hypothesise that 5mg and 10mg of Nebivolol will be effective and well tolerated by black hypertensive patients residing in Nigeria.

The primary objective is to study the effect of 5mg and 10mg of Nebivolol on blood pressure control in Black African hypertensive patients residing in Nigeria. The secondary objectives are: to evaluate the rates of BP control (<140 mmHg systolic and <90 mmHg diastolic) achieved with 5mg and 10mg of Nebivolol respectively; to evaluate the incidence and the nature of adverse events with these two doses of Nebivolol; to evaluate the effects of these two doses of Nebivolol on fasting blood sugar and fasting lipid profile, and to evaluate the effect of these two doses on erectile dysfunction The primary outcome measure is change in office BP value from baseline to 2 months. This will be calculated as the difference between the mean office BP at randomization and that at the end of follow up. And the secondary endpoints are: to determine the proportion of patients who achieve BP <140 mmHg systolic and <90 mmHg diastolic in two months; to determine the proportion of patients who have adverse events with both doses of Nebivolol respectively; to study the change in plasma fasting blood sugar and fasting lipid profile over two months, and to see proportion of male patients who complain of erectile dysfunction on follow up and end of the study.

It is is a prospective, observational program among hypertensive patients with 3 months follow up.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Nigeria
  • FCT
    • Abuja, FCT, Nigeria, 90001
      • Africa International College
  • Federal Capital Territory
    • Abuja, Federal Capital Territory, Nigeria, 90001
      • University of Abuja Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

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Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertensives to receiving Nevibolol; Patients to receive Nevibolol	Drug: The Efficacy and Tolerability of Nebivolol in Nigerians; To determine the effect of Nevibolol on office blood pressure of Blacks residing in Nigeria; Other Names: Effect of Nebivolol in Nigeria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in office blood pressure	The primary outcome measure is change in office BP value from baseline to 2 months	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in metabolic profile	Change in plasma fasting blood sugar and fasting lipid profile over two months.	2 months
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

Collaborators and Investigators

• Sponsor: University of Abuja
• Collaborators: Micronova Pharmaceuticals Ind Ltd

Publications and helpful links

General Publications

• Ojji D, Ale BM, Shedul L, Umuerri E, Ejim E, Alikor C, Agunyenwa C, Njideofor U, Eze H, Ansa V. The Effect of Nebivolol on Office Blood Pressure of Blacks Residing in Sub-Saharan Africa (A Pilot Study). Front Cardiovasc Med. 2021 Jan 11;7:613917. doi: 10.3389/fcvm.2020.613917. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Actual): December 27, 2018
• Study Completion (Actual): April 27, 2019

Study Registration Dates

• First Submitted: July 15, 2018
• First Submitted That Met QC Criteria: July 15, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-1 Receptor Agonists; Nebivolol
• Other Study ID Numbers: UAbuja

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No