Skip to main content
OpenTrials
Completed

NCT Number: NCT01415505

Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension

The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forest Investigative Site 083, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • A medical contraindication to discontinuing a current antihypertensive therapy
  • History of Type 1 diabetes mellitus

Treatment and study plan

Nebivolol, Valsartan and Hydrochlorothiazide

Drug

Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration

Primary outcomes

  1. Adverse Event Recording

    Time frame: From Baseline to Week 53 (Visit 16)

Secondary outcomes

  1. Diastolic Blood Pressure (DBP).

    Time frame: From Baseline to Week 52 (Visit 15)

  2. Systolic Blood Pressure (SBP)

    Time frame: From Baseline to Week 52 (Visit 15)

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Multicenter, Open-Label, Single-Arm, Free Tablet Combination, Long-Term Study to Evaluate the Safety of Nebivolol in Combination With Valsartan in Patients With Stage 1 or Stage 2 Essential Hypertension

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2011
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.