CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 664 enrolled
Drug / intervention
nebivolol and lisinopril (free combination) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01218100
NCT01218100Phase 4Completed
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A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension

Forest Laboratories·interventional·Posted Oct 11, 2010·Updated Jun 21, 2012

In Brief

A Phase 4 clinical trial evaluating nebivolol and lisinopril (free combination), nebivolol monotherapy, and 2 other interventions for Stage 2 Diastolic Hypertension. Completed, enrolled 664 participants across 90 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage 2 Diastolic Hypertension
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 11, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.7 years ago

Interventions

nebivolol and lisinopril (free combination)drug

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

nebivolol monotherapydrug

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

lisinopril monotherapydrug

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

placebodrug

Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks