Completed
PHASE4
INTERVENTIONAL
NCT01218100
Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
View on ClinicalTrials.gov
Updated Dec 15, 2025
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).
Interventions
Name:
nebivolol and lisinopril (free combination)
Type:
DRUG
Description:
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
Name:
nebivolol monotherapy
Type:
DRUG
Description:
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
Name:
lisinopril monotherapy
Type:
DRUG
Description:
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
Name:
placebo
Type:
DRUG
Description:
Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks
Primary Outcomes
Measure:
The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.
TimeFrame:
Visit 6/(Week 0) and Visit 9/(Week 6)
Description:
Trial Information
NCT ID
NCT01218100
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Forest Laboratories
Last Updated
December 15, 2025