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

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 19, 2007
Last Updated Date	January 12, 2009
Start Date ^ICMJE	October 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: October 19, 2007)	Patient responses on a Patient Symptoms Questoinnaire (PSQ)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00547300 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 19, 2007)	Peripheral blood pressure (BP), Central aortic pressure
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-Release (ER) for Hypertension
Official Title ^ICMJE	Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide
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)
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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Drug: Nebivolol, Metoprolol ER, Hydrochlorothiazide Nebivolol QD, Oral Admin Metoprolol ER QD, Oral Admin Hydrochlorothiazide, QD, Oral Admin
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	400
Completion Date	October 2008
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00547300
Other Study ID Numbers ^ICMJE	NEB-MD-03
Has Data Monitoring Committee	Not Provided
Responsible Party	Carol Satler MD, PhD Vice President, Clinical Development, Cardiovascular & Respiratory, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE	Mylan Laboratories
Investigators ^ICMJE	Not Provided
Information Provided By	Forest Laboratories
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top