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Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

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.
 
ClinicalTrials.gov Identifier: NCT00734630
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : April 26, 2011
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Forest Laboratories

Study Description
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Brief Summary:
This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Condition or disease Intervention/treatment Phase
Hypertension Drug: nebivolol Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added To Antihypertensive Treatment With Lisinopril or Losartan in Patients With Hypertension.
Study Start Date : August 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nebivolol
Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration
 Drug: nebivolol

Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily

Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Other Name: Bystolic ™
Placebo Comparator: Placebo
Matching placebo tablets, oral administration
 Drug: Placebo
Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration
Other Names:
  • Lisinopril-other names: Prinivil, Zestril
  • Losartan-other name: Cozaar


Outcome Measures
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Primary Outcome Measures :
  1. Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12 [ Time Frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12) ]
    Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).


Secondary Outcome Measures :
  1. Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12 [ Time Frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12) ]
    Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, ambulatory outpatients 18-85 years old at screening
  • Have a history of hypertension
  • Qualifying laboratory results

Exclusion Criteria:

  • Severe hypertension, including chronic kidney disease
  • Documented congestive heart failure
  • Have clinically significant respiratory, liver, or heart disease
  • History of stroke, heart attack, or heart surgery in the last 6 months
  • Have a history of hypersensitivity to nebivolol or other beta blockers.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00734630


Locations
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Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Manfred Stapff, MD, PhD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Noah Rosenberg , MD, Exec. Dir, Clin Dev, Cardiovascular and Metabolism, Forest Research Institute, a Subsidairy of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00734630    
Other Study ID Numbers: NEB-MD-11
First Posted: August 14, 2008    Key Record Dates
Results First Posted: April 26, 2011
Last Update Posted: April 26, 2011
Last Verified: March 2011
Keywords provided by Forest Laboratories:
nebivolol
Bystolic ™
lisinopril
losartan
Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Lisinopril
Nebivolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents