Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Stage 2 Diastolic Hypertension

Treatments: Drug: nebivolol monotherapy; Drug: lisinopril monotherapy; Drug: placebo; Drug: nebivolol and lisinopril (free combination)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01218100

NEB-MD-25

Details and patient eligibility

About

This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP>= 100 mmHg).

Enrollment: 664 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female outpatients 18 to 64 years of age
• Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
• stage 2 diastolic hypertension (DBP >= 100 mmHg)

Exclusion criteria

• secondary hypertension
• evidence of other concurrent disease or conditions that might interfere with the conduct of the study
• participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, of Screening (Visit 1).
• have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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664 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Combination group - starting dose level nebivolol 5mg and lisinopril 10mg

Treatment:

Drug: nebivolol and lisinopril (free combination)

2

Active Comparator group

Description:

Nebivolol monotherapy group - starting dose level nebivolol 5mg

Treatment:

Drug: nebivolol monotherapy

3

Active Comparator group

Description:

Lisinopril monotherapy group - starting dose level lisinopril 10mg

Treatment:

Drug: lisinopril monotherapy

4

Placebo Comparator group

Description:

Placebo group - starting dose is placebo

Treatment:

Drug: placebo