Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00734630

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:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Lisinopril Losartan Nebivolol Losartan potassium Nebivolol Hydrochloride

U.S. FDA Resources

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

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

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 May 24, 2012