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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
  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:


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:
    Drug: Nebivolol, Metoprolol ER, Hydrochlorothiazide
    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
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:
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
Cardiovascular Diseases
Vascular Diseases
Hydrochlorothiazide
Metoprolol
Metoprolol succinate
Nebivolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Sympatholytics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014