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

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ClinicalTrials.gov Identifier: NCT00547300
Recruitment Status : Terminated
First Posted : October 22, 2007
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
Mylan Laboratories
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE October 19, 2007
First Posted Date  ICMJE October 22, 2007
Results First Submitted Date  ICMJE October 19, 2010
Results First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE October 31, 2007
Actual Primary Completion Date January 2, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score [ Time Frame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12) ]
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2007)
Patient responses on a Patient Symptoms Questoinnaire (PSQ)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Peripheral Blood Pressure (BP) [ Time Frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) ]
  • Pulse Rate [ Time Frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2007)
Peripheral blood pressure (BP), Central aortic pressure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
Official Title  ICMJE Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Metoprolol ER
    Metoprolol ER once daily, oral administration
  • Drug: Nebivolol
    Nebivolol once daily, oral administration
Study Arms  ICMJE
  • Experimental: Nebivolol
    Nebivolol 5 mg, 10 mg or 20 mg
    Intervention: Drug: Nebivolol
  • Active Comparator: Metoprolol ER
    Metoprolol ER 50 mg, 100 mg or 200 mg
    Intervention: Drug: Metoprolol ER
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 30, 2019)
49
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2007)
400
Actual Study Completion Date  ICMJE January 2, 2008
Actual Primary Completion Date January 2, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00547300
Other Study ID Numbers  ICMJE NEB-MD-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Mylan Laboratories
Investigators  ICMJE Not Provided
PRS Account Forest Laboratories
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP