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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

NCT01508026 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4161

Last updated 2014-04-25

No results posted yet for this study

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.

Conditions

  • Stage 1 Hypertension
  • Stage 2 Hypertension

Interventions

DRUG

Nebivolol 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

DRUG

Nebivolol 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

DRUG

Nebivolol 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

DRUG

Nebivolol 1

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

DRUG

Nebivolol 2

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

DRUG

Valsartan 1

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

DRUG

Valsartan 2

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

DRUG

Placebo

Dose matched placebo, oral administration

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • David B Bharucha, MD, PhD, FACC · Forest Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-03-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01508026 on ClinicalTrials.gov