A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Nebivolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00785512

NEB-MD-17

Details and patient eligibility

About

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

Enrollment: 207 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female outpatients 18 to 79 years of age
• Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
• meet criteria for stage I or II hypertension
• currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion criteria

• type 1 or type 2 diabetes
• secondary hypertension
• evidence of other concurrent disease or conditions that might interfere with the conduct of the study
• treatment with any investigational study drug within 30 days of Screening (Visit 1)
• have a history of hypersensitivity to nebivolol or other β-blockers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

207 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration

Treatment:

Drug: Nebivolol

2

Placebo Comparator group

Description:

Matching placebo tablets, oral administration

Treatment:

Drug: Placebo