Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00547300 |
Recruitment Status :
Terminated
First Posted : October 22, 2007
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
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Sponsor:
Forest Laboratories
Collaborator:
Mylan Laboratories
Information provided by (Responsible Party):
Forest Laboratories
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Hypertension |
Interventions |
Drug: Metoprolol ER Drug: Nebivolol |
Enrollment | 49 |
Participant Flow
Recruitment Details | Patient recruitment occurred over a four month period from October 2007 to January 2008 at 39 US sites. |
Pre-assignment Details | All patients went through a 4 week hydrochlorothiazide (HCTZ) run-in phase before randomization. |
Arm/Group Title | Nebivolol | Metoprolol Extended-Release (ER) |
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Nebivolol 5 mg, 10 mg or 20 mg | Metoprolol ER 50 mg, 100 mg or 200 mg |
Period Title: Overall Study | ||
Started | 25 | 26 [1] |
Completed | 0 [2] | 0 [2] |
Not Completed | 25 | 26 |
Reason Not Completed | ||
Study was Administratively Terminated | 25 | 24 |
Did not Meet Entry Criteria | 0 | 2 |
[1]
Two (2) patients were randomized in error, but no study medication taken.
[2]
No patients completed because the study was administratively terminated.
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Baseline Characteristics
Arm/Group Title | Nebivolol | Metoprolol Extended-Release (ER) | Total | |
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Nebivolol 5 mg, 10 mg or 20 mg | Metoprolol ER 50 mg, 100 mg or 200 mg | Total of all reporting groups | |
Overall Number of Baseline Participants | 25 | 24 | 49 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | 24 participants | 49 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
22 88.0%
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19 79.2%
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41 83.7%
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>=65 years |
3 12.0%
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5 20.8%
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8 16.3%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 25 participants | 24 participants | 49 participants | |
55.0 (8.67) | 57.0 (9.32) | 56.0 (8.95) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | 24 participants | 49 participants | |
Female |
13 52.0%
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11 45.8%
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24 49.0%
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Male |
12 48.0%
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13 54.2%
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25 51.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 25 participants | 24 participants | 49 participants |
25 100.0%
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24 100.0%
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49 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
Study was terminated early due to administrative reasons. Formal analyses of primary and secondary endpoints were not conducted in this study.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor can review results communications prior to public release & can embargo communications re: results for 60 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential information. Upon sponsor's request, PI shall delete any proprietary info & shall not include raw data in the publication. On sponsor's request, PI shall delay submission for any pub while sponsor files patent applications. Any publication will give recognition to Sponsor's support.
Results Point of Contact
Name/Title: | Therapeutic Area Head |
Organization: | Allergan |
Phone: | 714-246-4500 |
EMail: | clinicaltrials@allergan.com |
Responsible Party: | Forest Laboratories |
ClinicalTrials.gov Identifier: | NCT00547300 |
Other Study ID Numbers: |
NEB-MD-03 |
First Submitted: | October 19, 2007 |
First Posted: | October 22, 2007 |
Results First Submitted: | October 19, 2010 |
Results First Posted: | May 21, 2019 |
Last Update Posted: | May 21, 2019 |