Conditions: Stage 2 Diastolic Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 664
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP\>= 100 mmHg).

Detailed description:

Arms:
arm 1: Combination group - starting dose level nebivolol 5mg and lisinopril 10mg arm 2: Nebivolol monotherapy group - starting dose level nebivolol 5mg arm 3: Lisinopril monotherapy group - starting dose level lisinopril 10mg arm 4: Placebo group - starting dose is placebo

Interventions: intervention 1: nebivolol and lisinopril (free combination) intervention 2: nebivolol monotherapy intervention 3: lisinopril monotherapy intervention 4: placebo
Intervention descriptions: intervention 1: nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks

nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks

nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks intervention 2: nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks

nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)

nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks intervention 3: lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks intervention 4: Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks

Protocol document: