To Determine the Effect of Nebivolol on Office Blood Pressure of Blacks Residing in Nigeria
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

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.
    

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.
    

Intervention name(s): The Efficacy and Tolerability of Nebivolol in Nigerians
Intervention type(s): Drug
Intervention description(s): To determine the effect of Nevibolol on office blood pressure of Blacks residing in Nigeria
Other intervention name(s): Effect of Nebivolol in Nigeria
Intervention MeSH terms: Nebivolol
Observational model: Other
Time perspective: Prospective
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.