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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01508026

Enrollment

4161

Registered

2012-01-11

Start date

2012-01-31

Completion date

2013-05-31

Last updated

2014-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage 1 Hypertension, Stage 2 Hypertension

Keywords

Stage 1, Stage 2, Hypertension

Brief summary

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.

Interventions

DRUGNebivolol 2

Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration

DRUGValsartan 1

Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration

DRUGNebivolol and Valsartan 1

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

DRUGNebivolol and Valsartan 2

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

DRUGNebivolol and Valsartan 3

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

DRUGNebivolol 1

Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration

DRUGValsartan 2

Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration

DRUGPlacebo

Dose matched placebo, oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in Sitting Diastolic Blood Pressure (DBP)	from basline to Week 8

Secondary

Measure	Time frame
Change in Sitting Systolic Blood Pressure (SBP)	from baseline to Week 8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026