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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Nebivolol, Valsartan and Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415505

NAC-MD-02

Details and patient eligibility

About

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.

Enrollment: 812 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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812 participants in 1 patient group

1

Other group

Description:

Nebivolol and Valsartan free tablet combination

Treatment:

Drug: Nebivolol, Valsartan and Hydrochlorothiazide