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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Stage 1 Hypertension; Stage 2 Hypertension

Treatments: Drug: Nebivolol and Valsartan 3; Drug: Placebo; Drug: Valsartan 1; Drug: Valsartan 2; Drug: Nebivolol 1; Drug: Nebivolol 2; Drug: Nebivolol and Valsartan 2; Drug: Nebivolol and Valsartan 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01508026

NAC-MD-01

Details and patient eligibility

About

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.

Enrollment: 4,161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4,161 participants in 8 patient groups, including a placebo group

Nebivolol and Valsartan Fixed Dose Combination 1

Experimental group

Description:

Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg

Treatment:

Drug: Nebivolol and Valsartan 1

Nebivolol and Valsartan Fixed Dose Combination 2

Experimental group

Description:

Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg

Treatment:

Drug: Nebivolol and Valsartan 2

Nebivolol and Valsartan Fixed Dose Combination 3

Experimental group

Description:

Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg

Treatment:

Drug: Nebivolol and Valsartan 3

Nebivolol Low Dose

Experimental group

Description:

Nebivolol Monotherapy 5 mg

Treatment:

Drug: Nebivolol 1

Nebivolol High Dose

Experimental group

Description:

Nebivolol Monotherapy 20 mg

Treatment:

Drug: Nebivolol 2

Valsartan Low Dose

Experimental group

Description:

Valsartan Monotherapy 80 mg

Treatment:

Drug: Valsartan 1

Valsartan High Dose

Experimental group

Description:

Valsartan Monotherapy 160 mg

Treatment:

Drug: Valsartan 2

Placebo

Placebo Comparator group

Description:

Dose Matched placebo

Treatment:

Drug: Placebo