Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed Dose Combination in Patients With Stage 1 or 2 Essential Hypertension

Conditions
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Stage 1 Hypertension, Stage 2 Hypertension

Intervention / Treatment
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* Drug: Nebivolol and Valsartan 1
* Drug: Nebivolol and Valsartan 2
* Drug: Nebivolol and Valsartan 3
* Drug: Nebivolol 1
* Drug: Nebivolol 2
* Drug: Valsartan 1
* Drug: Valsartan 2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients of age 18 years or above Patients diagnosed with stage 1 or stage 2 essential hypertension Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant Exclusion Criteria: Secondary hypertension or severe hypertension Clinically significant cardiovascular disease or heart failure Clinical significant respiratory disease that would prohibit the use of a beta blocker A medical contraindication to discontinuing a current antihypertensive therapy History of Type 1 diabetes mellitus History of Severe Mental Illness except mild depression

Ages Eligible for Study
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Minimum Age: 18 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: Nebivolol and Valsartan Fixed Dose Combination 1<br>Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg | Drug: Nebivolol and Valsartan 1<br>* Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg, oral administration, then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration<br>|
| Experimental: Nebivolol and Valsartan Fixed Dose Combination 2<br>Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg | Drug: Nebivolol and Valsartan 2<br>* Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 320 mg, oral administration<br>|
| Experimental: Nebivolol and Valsartan Fixed Dose Combination 3<br>Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg | Drug: Nebivolol and Valsartan 3<br>* Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 20 mg and Valsartan 320 mg, oral administration<br>|
| Experimental: Nebivolol Low Dose<br>Nebivolol Monotherapy 5 mg | Drug: Nebivolol 1<br>* Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration<br>|
| Experimental: Nebivolol High Dose<br>Nebivolol Monotherapy 20 mg | Drug: Nebivolol 2<br>* Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration<br>|
| Experimental: Valsartan Low Dose<br>Valsartan Monotherapy 80 mg | Drug: Valsartan 1<br>* Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration<br>|
| Experimental: Valsartan High Dose<br>Valsartan Monotherapy 160 mg | Drug: Valsartan 2<br>* Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration<br>|
| Placebo Comparator: Placebo<br>Dose Matched placebo | Drug: Placebo<br>* Dose matched placebo, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sitting Diastolic Blood Pressure (DBP) |  | from basline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sitting Systolic Blood Pressure (SBP) |  | from baseline to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage 1, Stage 2, Hypertension