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

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. Identifier: NCT00547300
Recruitment Status : Terminated
First Posted : October 22, 2007
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Mylan Laboratories
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

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

Detailed Description:
This study was 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. Up-titration 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)
Actual Study Start Date : October 31, 2007
Actual Primary Completion Date : January 2, 2008
Actual Study Completion Date : January 2, 2008

Arm Intervention/treatment
Experimental: Nebivolol
Nebivolol 5 mg, 10 mg or 20 mg
Drug: Nebivolol
Nebivolol once daily, oral administration

Active Comparator: Metoprolol ER
Metoprolol ER 50 mg, 100 mg or 200 mg
Drug: Metoprolol ER
Metoprolol ER once daily, oral administration

Primary Outcome Measures :
  1. Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score [ Time Frame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12) ]
    The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).

Secondary Outcome Measures :
  1. Peripheral Blood Pressure (BP) [ Time Frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) ]
  2. Pulse Rate [ Time Frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) ]

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Male or female, ambulatory outpatients
  • 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 (Visit 1)
  • SBP of 140-165 mm Hg and DBP > 90 mmHg at randomization (Visit 3)

Exclusion Criteria:

  • Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)
  • 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
  • Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)
  • History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1)
  • Use of antipsychotic medication (e.g., dopamine 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 (Visit 1)
  • History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs

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 identifier (NCT number): NCT00547300

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Sponsors and Collaborators
Forest Laboratories
Mylan Laboratories
Additional Information:
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Responsible Party: Forest Laboratories Identifier: NCT00547300    
Other Study ID Numbers: NEB-MD-03
First Posted: October 22, 2007    Key Record Dates
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019
Last Verified: April 2019
Keywords provided by Forest Laboratories:
Beta blocker
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
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
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists