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

This study has been completed.
Mylan Laboratories
Information provided by:
Forest Laboratories Identifier:
First received: October 19, 2007
Last updated: January 12, 2009
Last verified: January 2009

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 Intervention Phase
Drug: Nebivolol, Metoprolol ER, Hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

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

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

Estimated Enrollment: 400
Study Start Date: October 2007
Estimated Study Completion Date: October 2008
Intervention Details:
    Drug: Nebivolol, Metoprolol ER, Hydrochlorothiazide
    Nebivolol QD, Oral Admin Metoprolol ER QD, Oral Admin Hydrochlorothiazide, QD, Oral Admin
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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00547300

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

Additional Information:
No publications provided

Responsible Party: Carol Satler MD, PhD Vice President, Clinical Development, Cardiovascular & Respiratory, Forest Research Institute, a subsidiary of Forest Laboratories Inc. Identifier: NCT00547300     History of Changes
Other Study ID Numbers: NEB-MD-03
Study First Received: October 19, 2007
Last Updated: January 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Beta blocker

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Vasodilator Agents processed this record on April 16, 2014