Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension

NCT01415505 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 812

Last updated 2013-06-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.

Conditions

Interventions

DRUG

Nebivolol, Valsartan and Hydrochlorothiazide

Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • David B Bharucha, MD, PhD, FACC · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-01-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415505 on ClinicalTrials.gov