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

Hypertension Clinical Trial

Official title:

Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00547300
• Other study ID #: NEB-MD-03
• Status: Terminated
• Phase: Phase 3
• Start date: October 31, 2007
• Est. completion date: January 2, 2008

Study information

• Verified date: April 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: January 2, 2008
• Est. primary completion date: January 2, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Metoprolol ER
Metoprolol ER once daily, oral administration
• Nebivolol
Nebivolol once daily, oral administration

Locations

Country	Name	City	State
United States	Forest Research Institute 009	Atlanta	Georgia
United States	Forest Research Institute 028	Beverly Hills	California
United States	Forest Research Institute 014	Birmingham	Alabama
United States	Forest Research Institute 040	Bountiful	Utah
United States	Forest Research Institute 003	Carrollton	Texas
United States	Forest Investigative Site 002	Charleston	South Carolina
United States	Forest Research Institute 010	DeLand	Florida
United States	Forest Research Institute 054	Encinitas	California
United States	Forest Research Institute 032	Greenville	South Carolina
United States	Forest Research Institute 019	Holly Hill	Florida
United States	Forest Research Institute 036	Hollywood	Florida
United States	Forest Research Institute 027	Las Vegas	Nevada
United States	Forest Research Institute 008	Nashville	Tennessee
United States	Forest Research Institute 006	Oxon Hill	Maryland
United States	Forest Research Institute 007	Pembroke Pines	Florida
United States	Forest Research Institute 025	Roseville	California
United States	Forest Research Institute 050	Salisbury	North Carolina
United States	Forest Research Institute 012	San Antonio	Texas
United States	Forest Research Institute 048	Sugar Land	Texas
United States	Forest Research Institute 013	Tustin	California
United States	Forest Research Institute 053	Vista	California
United States	Forest Research Institute 052	Walnut Creek	California
United States	Forest Research Institute 033	Westlake Village	California
United States	Forest Research Institute 039	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Mylan Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score	The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).	Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
Secondary	Peripheral Blood Pressure (BP)		Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
Secondary	Pulse Rate		Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

External Links

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