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

Forest Laboratories812 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

812

Conditions

Hypertension

Interventions

Nebivolol, Valsartan and HydrochlorothiazideDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female outpatients of age 18 years or above * Patients diagnosed with stage 1 or stage 2 essential hypertension * Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant Exclusion Criteria: * Secondary hypertension or severe hypertension * Clinically significant cardiovascular disease or heart failure * A medical contraindication to discontinuing a current antihypertensive therapy * History of Type 1 diabetes mellitus

Locations (135)

Outcomes

Primary Outcomes

Adverse Event Recording

Time frame: From Baseline to Week 53 (Visit 16)

Secondary Outcomes

Diastolic Blood Pressure (DBP).

Time frame: From Baseline to Week 52 (Visit 15)

Systolic Blood Pressure (SBP)

Time frame: From Baseline to Week 52 (Visit 15)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Forest Investigative Site 083

Birmingham, Alabama, United States

Forest Investigative Site 004

Foley, Alabama, United States

Forest Investigative Site 038

Gulf Shores, Alabama, United States

Forest Investigative Site 124

Muscle Shoals, Alabama, United States

Forest Investigative Site 023

Chandler, Arizona, United States

Forest Investigative Site 073

Goodyear, Arizona, United States

Forest Investigative Site 100

Green Valley, Arizona, United States

Forest Investigative Site 117

Mesa, Arizona, United States

Forest Investigative Site 065

Mesa, Arizona, United States

Forest Investigative Site 102

Phoenix, Arizona, United States

...and 125 more locations