Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01415505
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol, Valsartan and Hydrochlorothiazide Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 812 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Nebivolol and Valsartan free tablet combination
Drug: Nebivolol, Valsartan and Hydrochlorothiazide
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 Outcome Measures :
  1. Adverse Event Recording [ Time Frame: From Baseline to Week 53 (Visit 16) ]

Secondary Outcome Measures :
  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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01415505

  Show 135 Study Locations
Sponsors and Collaborators
Forest Laboratories
Layout table for investigator information
Study Director: David B Bharucha, MD, PhD, FACC Forest Laboratories

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Forest Laboratories Identifier: NCT01415505     History of Changes
Other Study ID Numbers: NAC-MD-02
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: May 2013
Keywords provided by Forest Laboratories:
Stage 1
Stage 2
1 year open label safety study
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents