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 :
Terminated
First Posted : October 22, 2007
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Metoprolol ER Drug: Nebivolol | Phase 3 |
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
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Drug: Nebivolol
Nebivolol once daily, oral administration |
Active Comparator: Metoprolol ER
Metoprolol ER 50 mg, 100 mg or 200 mg
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Drug: Metoprolol ER
Metoprolol ER once daily, oral administration |
- 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).
- Peripheral Blood Pressure (BP) [ Time Frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) ]
- Pulse Rate [ Time Frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) ]

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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

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

Responsible Party: | Forest Laboratories |
ClinicalTrials.gov 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 |
Hypertension Nebivolol Beta blocker Tolerability |
Hypertension Vascular Diseases Cardiovascular Diseases Metoprolol Nebivolol Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics 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 |