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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension

Conditions
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Stage 2 Diastolic Hypertension

Intervention / Treatment
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* Drug: nebivolol and lisinopril (free combination)
* Drug: nebivolol monotherapy
* Drug: lisinopril monotherapy
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Combination group - starting dose level nebivolol 5mg and lisinopril 10mg | Drug: nebivolol and lisinopril (free combination)<br>* nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks<br>|
| Active Comparator: 2<br>Nebivolol monotherapy group - starting dose level nebivolol 5mg | Drug: nebivolol monotherapy<br>* nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only) nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks<br>|
| Active Comparator: 3<br>Lisinopril monotherapy group - starting dose level lisinopril 10mg | Drug: lisinopril monotherapy<br>* lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks<br>|
| Placebo Comparator: 4<br>Placebo group - starting dose is placebo | Drug: placebo<br>* Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. |  | Visit 6/(Week 0) and Visit 9/(Week 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6. |  | Visit 6/(Week 0) and Visit 9/(Week 6) |