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Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-Release (ER) for Hypertension

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ClinicalTrials.gov Identifier: NCT00547300
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : January 13, 2009
Sponsor:
Collaborator:
Mylan Laboratories
Information provided by:
Forest Laboratories

Study Description
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Brief Summary:
The purpose of this study is to compare the tolerability of nebivolol to metoprolol ER in a populatoin of patients with mild to moderate hypertension also receiving hydrochlorothiazide (HCTZ)

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol, Metoprolol ER, Hydrochlorothiazide Phase 3

Detailed Description:
This study is an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ. It is a multi-center, randomized, double blind (DB), active-control, parallel-group study, starting with a 4-week HCTZ run-in phase, followed by a 12-week DB treatment phase. Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol ER. Uptitration of dose of study drug will occur if needed during the first 4 weeks of the DB phase, after which there is an 8-week stable-dose period of treatment. A 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide
Study Start Date : October 2007
Study Completion Date : October 2008

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Arms and Interventions
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Intervention Details:
  • Drug: Nebivolol, Metoprolol ER, Hydrochlorothiazide
    Nebivolol QD, Oral Admin Metoprolol ER QD, Oral Admin Hydrochlorothiazide, QD, Oral Admin

Outcome Measures
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Primary Outcome Measures :
  1. Patient responses on a Patient Symptoms Questoinnaire (PSQ)

Secondary Outcome Measures :
  1. Peripheral blood pressure (BP), Central aortic pressure

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, ambulatory outpatients 18-80 yo. Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
  • History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine
  • SBP of 135-155 mm Hg and/or DBP of >85 mm Hg at Screening
  • Vision and hearing (hearing aid permissable) sufficient for compliance with testing procedures (i.e., with phone- and/or internet-based assessments)

Exclusion Criteria:

  • Treatment with a beta-blocker or clonidine within 6 months of Screening
  • Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
  • Coronary artery disease requiring treatment with a calcium channel blocker or nitrates
  • Cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening
  • History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening
  • Use of antipsychotic medicaiton (e.g., dopanine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants
  • Diabetes mellitus, type I or II
  • Participation in a previous investigational study of nebivolol at any time
  • Receipt of treatment with an investigational study drug within 30 days of screening
  • History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs
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): NCT00547300


Locations
United States, Missouri
For information regarding investigative sites, contact Forest Professional Affairs
St. Louis, Missouri, United States, 63045
Sponsors and Collaborators
Forest Laboratories
Mylan Laboratories
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Carol Satler MD, PhD Vice President, Clinical Development, Cardiovascular & Respiratory, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00547300     History of Changes
Other Study ID Numbers: NEB-MD-03
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: January 2009

Keywords provided by Forest Laboratories:
Hypertension
Nebivolol
Beta blocker
Tolerability

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Metoprolol
Nebivolol
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists