Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Nebivolol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415531

NEB-MD-28

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Enrollment: 641 patients

Sex: All

Ages: 18 to 54 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female outpatients, of age 18 - 54 years
• Patients diagnosed with stage 1 or stage 2 essential hypertension
• Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion criteria

• Secondary hypertension or severe hypertension
• History of Type 1 diabetes mellitus
• A medical contraindication to discontinuing a current antihypertensive therapy
• Clinically significant respiratory disease that prohibit use of a beta blocker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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641 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration

Treatment:

Drug: Nebivolol

2

Placebo Comparator group

Description:

Dose-matched placebo

Treatment:

Drug: Placebo