Clinical trial NCT00547300: Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
Official title: Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
Nebivolol
Beta blocker
Tolerability
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Mylan Laboratories
First posted: 2007-10-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

Detailed description: This study was 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. Up-titration 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 criteria: Inclusion Criteria:

* Male or female, ambulatory outpatients
* 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 (Visit 1)
* SBP of 140-165 mm Hg and DBP \> 90 mmHg at randomization (Visit 3)

Exclusion Criteria:

* Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)
* 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
* Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)
* History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1)
* Use of antipsychotic medication (e.g., dopamine 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 (Visit 1)
* History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs

Primary outcomes:
measure: Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
timeFrame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
Secondary outcomes:
measure: Peripheral Blood Pressure (BP)
timeFrame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
measure: Pulse Rate
timeFrame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Research Institute 014
state: Alabama
city: Beverly Hills
country: United States
facility: Forest Research Institute 028
state: California
city: Encinitas
country: United States
facility: Forest Research Institute 054
state: California
city: Roseville
country: United States
facility: Forest Research Institute 025
state: California
city: Tustin
country: United States
facility: Forest Research Institute 013
state: California
city: Vista
country: United States
facility: Forest Research Institute 053
state: California
city: Walnut Creek
country: United States
facility: Forest Research Institute 052
state: California
city: Westlake Village
country: United States
facility: Forest Research Institute 033
state: California
city: DeLand
country: United States
facility: Forest Research Institute 010
state: Florida
city: Holly Hill
country: United States
facility: Forest Research Institute 019
state: Florida
city: Hollywood
country: United States
facility: Forest Research Institute 036
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Research Institute 007
state: Florida
city: Atlanta
country: United States
facility: Forest Research Institute 009
state: Georgia
city: Oxon Hill
country: United States
facility: Forest Research Institute 006
state: Maryland
city: Las Vegas
country: United States
facility: Forest Research Institute 027
state: Nevada
city: Salisbury
country: United States
facility: Forest Research Institute 050
state: North Carolina
city: Wilmington
country: United States
facility: Forest Research Institute 039
state: North Carolina
city: Charleston
country: United States
facility: Forest Investigative Site 002
state: South Carolina
city: Greenville
country: United States
facility: Forest Research Institute 032
state: South Carolina
city: Nashville
country: United States
facility: Forest Research Institute 008
state: Tennessee
city: Carrollton
country: United States
facility: Forest Research Institute 003
state: Texas
city: San Antonio
country: United States
facility: Forest Research Institute 012
state: Texas
city: Sugar Land
country: United States
facility: Forest Research Institute 048
state: Texas
city: Bountiful
country: United States
facility: Forest Research Institute 040
state: Utah
Study officials:
References: