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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00734630
First received: August 13, 2008
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.


Condition Intervention Phase
Hypertension
Drug: nebivolol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12 [ Time Frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12) ] [ Designated as safety issue: No ]
    Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).


Secondary Outcome Measures:
  • Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12 [ Time Frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12) ] [ Designated as safety issue: No ]
    Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).


Enrollment: 491
Study Start Date: August 2008
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734630

  Show 75 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Manfred Stapff, MD, PhD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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     History of Changes
Other Study ID Numbers: NEB-MD-11
Study First Received: August 13, 2008
Results First Received: March 31, 2011
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
nebivolol
Bystolic ™
lisinopril
losartan
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Antihypertensive Agents
Lisinopril
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 26, 2014