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Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00142584
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : March 12, 2008
Sponsor:
Information provided by:
Mylan Bertek Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date March 12, 2008
Study Start Date  ICMJE August 2005
Estimated Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
Change in average sitting DBP taken at trough at the end of treatment compared to baseline (baseline is defined as the baseline of the feeder study). [ Time Frame: During study. ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
Change in average sitting DBP taken at trough at the end of treatment compared to baseline (baseline is defined as the baseline of the feeder study).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
  • SBP, pulse pressure and heart rate at peak and trough drug effects measured in the supine, sitting and standing positions. [ Time Frame: During study. ]
  • Adverse events, ECGs, laboratory evaluations [ Time Frame: During study. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • SBP, pulse pressure and heart rate at peak and trough drug effects measured in the supine, sitting and standing positions.
  • Adverse events, ECGs, laboratory evaluations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
Official Title  ICMJE An Open-Label, Randomized Study Evaluating the Long-Term Effects of Metoprolol Versus Nebivolol as Monotherapy or in Combination With Amlodipine or Hydrochlorothiazide for the Treatment of Patients With Hypertension
Brief Summary The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension
Detailed Description Approximately 50 million Americans have hypertension defined as a systolic blood pressure (SBP) greater then or equal to 140 mmHg and/or a diastolic blood pressure (DBP) greater then or equal to 90 mmHg. To control blood pressure, more than 2 agents are required in many patients. The current study is a randomized, titration-to-effect, open-label, multi center study. Patients will be randomized to either nebivolol or metoprolol. The dose of the randomized treatment can be titrated as needed to achieve blood pressure control. If necessary, additional antihypertensive agents (calcium antagonist, diuretic, etc.) can be added to achieve control. Patients will be seen every 1-3 months for approximately 18 months to assess long-term safety, tolerability and effectiveness of nebivolol versus metoprolol.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Nebivolol
    Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.
  • Drug: Metoprolol
    Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.
Study Arms  ICMJE
  • Experimental: 1-NEB
    Nebivolol
    Intervention: Drug: Nebivolol
  • Active Comparator: 2-MET
    Metoprolol
    Intervention: Drug: Metoprolol
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 Completed
Estimated Enrollment  ICMJE
 (submitted: August 31, 2005)
1000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Estimated Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completion of previous nebivolol study
  • Stage 1-2 HTN at baseline of first study

Exclusion Criteria:

  • Recent myocardial infarction or stroke
  • Contraindications to beta blocker therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT00142584
Other Study ID Numbers  ICMJE NEB324
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Miller, Vice President-Regulatory Affairs, Mylan Inc.
Study Sponsor  ICMJE Mylan Bertek Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Betty S Riggs, MD, MBA Mylan Pharmaceuticals
PRS Account Mylan Bertek Pharmaceuticals
Verification Date August 2005

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