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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nebivolol, Metoprolol ER, Hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

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)

Clinical Details

Official title: Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Patient responses on a Patient Symptoms Questoinnaire (PSQ)

Secondary outcome: Peripheral blood pressure (BP), Central aortic pressure

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

For information regarding investigative sites, contact Forest Professional Affairs, St. Louis, Missouri 63045, United States
Additional Information

Starting date: October 2007
Last updated: January 12, 2009

Page last updated: August 23, 2015

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