Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: nebivolol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734630

NEB-MD-11

Details and patient eligibility

About

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Enrollment: 491 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, ambulatory outpatients 18-85 years old at screening
• Have a history of hypertension
• Qualifying laboratory results

Exclusion criteria

• Severe hypertension, including chronic kidney disease
• Documented congestive heart failure
• Have clinically significant respiratory, liver, or heart disease
• History of stroke, heart attack, or heart surgery in the last 6 months
• Have a history of hypersensitivity to nebivolol or other beta blockers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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491 participants in 2 patient groups, including a placebo group

Nebivolol

Active Comparator group

Description:

Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration

Treatment:

Drug: nebivolol

Placebo

Placebo Comparator group

Description:

Matching placebo tablets, oral administration

Treatment:

Drug: Placebo