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

NCT03598673 | Completed

• 1 other identifier: UAbuja
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in office blood pressure

  The primary outcome measure is change in office BP value from baseline to 2 months

  2 months

Secondary Outcomes (4)

• The proportion of patients who achieved blood control

  2 months

• Proportion of patients with adverse events

  1 month and 2 months

• Change in metabolic profile

  2 months

• Proportion of male patients with erectile dysfunction

  1 month and 2 months

Study Arms (1)

Hypertensives to receiving Nevibolol

Patients to receive Nevibolol

Drug: The Efficacy and Tolerability of Nebivolol in Nigerians

Interventions

The Efficacy and Tolerability of Nebivolol in Nigerians DRUG

To determine the effect of Nevibolol on office blood pressure of Blacks residing in Nigeria

Also known as: Effect of Nebivolol in Nigeria

Hypertensives to receiving Nevibolol

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Abuja: lead
• Micronova Pharmaceuticals Ind Ltd: collaborator

Study Sites (2)

Africa International College

Abuja, Federal Capital Territory, 90001, Nigeria

Location

University of Abuja Teaching Hospital

Abuja, Federal Capital Territory, 90001, Nigeria

Location

Related Publications (1)

• 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.

  PMID: 33505995 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 26, 2018
• Study Start: February 27, 2018
• Primary Completion: December 27, 2018
• Study Completion: April 27, 2019
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

NG (2)