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

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:

Drug Information available for: Hydrochlorothiazide Metoprolol Metoprolol tartrate Metoprolol fumarate Metoprolol succinate Nebivolol 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:

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Related Info This link exits the ClinicalTrials.gov site


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 Hydrochlorothiazide Metoprolol Nebivolol Antihypertensive Agents Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action	Anti-Arrhythmia Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Vasodilator Agents Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists

ClinicalTrials.gov processed this record on September 29, 2016