Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-Release (ER) for Hypertension
This study has been completed.
Sponsor:
Forest Laboratories
Collaborator:
Mylan Laboratories
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00547300
First received: October 19, 2007
Last updated: January 12, 2009
Last verified: January 2009
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Purpose
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 |
|---|---|---|
|
Hypertension |
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:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Hydrochlorothiazide
Metoprolol
Metoprolol tartrate
Metoprolol succinate
Nebivolol
Metoprolol fumarate
Nebivolol Hydrochloride
U.S. FDA Resources
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:
Detailed Description:
-
Drug: Nebivolol, Metoprolol ER, Hydrochlorothiazide
Nebivolol QD, Oral Admin Metoprolol ER QD, Oral Admin Hydrochlorothiazide, QD, Oral Admin
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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. |
| ClinicalTrials.gov 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:
|
Hypertension Nebivolol Beta blocker Tolerability |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Metoprolol Nebivolol Hydrochlorothiazide Metoprolol succinate Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions 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 Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Vasodilator Agents |
ClinicalTrials.gov processed this record on May 16, 2013