Nebivolol in Patients With Systolic Stage 2 Hypertension (NEB-MD-20)

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Nebivolol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057251

NEB-MD-20

Details and patient eligibility

About

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Enrollment: 433 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male of female, 18 to 64 years of age at screening
• mean seated heart rate at least 60 bpm
• diagnosed systolic stage 2 hypertension
• unremarkable physical exam findings

Exclusion criteria

• high risk due to secondary hypertension or former stage 3 hypertension by JNC6
• concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
• currently taking medication that cannot be stopped during the course of the study
• participating other clinical trials
• member of the study center personnel
• documented drug abuse
• contra indication to beta blocker
• abnormal lab finding
• poor compliance
• other conditions judged by investigator that is not suitable for the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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433 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Nebivolol

2

Placebo Comparator group

Treatment:

Drug: Placebo