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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

Study Type Interventional
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
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)
Hide Arm/Group Description 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.
Arm/Group Title Nebivolol Metoprolol Extended-Release (ER) Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  88.0%
19
  79.2%
41
  83.7%
>=65 years
3
  12.0%
5
  20.8%
8
  16.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 25 participants 24 participants 49 participants
Female
13
  52.0%
11
  45.8%
24
  49.0%
Male
12
  48.0%
13
  54.2%
25
  51.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 24 participants 49 participants
25
 100.0%
24
 100.0%
49
 100.0%
1.Primary Outcome
Title Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
Hide Description The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
Time Frame Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Formal analysis of the primary endpoint was not conducted in this abbreviated study as the study was terminated before visit 10 was reached.
Arm/Group Title Nebivolol Metoprolol Extended-Release (ER)
Hide Arm/Group Description:
Nebivolol 5 mg, 10 mg or 20 mg
Metoprolol ER 50 mg, 100 mg or 200 mg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Peripheral Blood Pressure (BP)
Hide Description [Not Specified]
Time Frame Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
Formal analysis of the secondary endpoint was not conducted in this abbreviated study as the study was terminated before all visits were completed. No patients completed the study.
Arm/Group Title Nebivolol Metoprolol Extended-Release (ER)
Hide Arm/Group Description:
Nebivolol 5 mg, 10 mg or 20 mg
Metoprolol ER 50 mg, 100 mg or 200 mg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Pulse Rate
Hide Description [Not Specified]
Time Frame Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
Formal analysis of the secondary endpoint was not conducted in this abbreviated study as the study was terminated before all visits were completed. No patients completed the study.
Arm/Group Title Nebivolol Metoprolol Extended-Release (ER)
Hide Arm/Group Description:
Nebivolol 5 mg, 10 mg or 20 mg
Metoprolol ER 50 mg, 100 mg or 200 mg
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Event data was collected over a four month period from October 2007 to January 2008.
Adverse Event Reporting Description Non-serious adverse events based on the safety population of (n=49).
 
Arm/Group Title Nebivolol Metoprolol Extended-Release (ER)
Hide Arm/Group Description Nebivolol 5 mg, 10 mg or 20 mg Metoprolol ER 50 mg, 100 mg or 200 mg
All-Cause Mortality
Nebivolol Metoprolol Extended-Release (ER)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
Hide Serious Adverse Events
Nebivolol Metoprolol Extended-Release (ER)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nebivolol Metoprolol Extended-Release (ER)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/25 (20.00%)   3/24 (12.50%) 
General disorders     
Pain † 1  2/25 (8.00%)  0/24 (0.00%) 
Infections and infestations     
Nasopharyngitis † 1  2/25 (8.00%)  1/24 (4.17%) 
Nervous system disorders     
Headache † 1  1/25 (4.00%)  2/24 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  2/25 (8.00%)  0/24 (0.00%) 
Rhinorrhoea † 1  2/25 (8.00%)  0/24 (0.00%) 
1
Term from vocabulary, MedDRA (10.1)
†
Indicates events were collected by systematic assessment
Study was terminated early due to administrative reasons. Formal analyses of primary and secondary endpoints were not conducted in this study.
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
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