Trial Outcomes & Findings for Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension (NCT NCT00547300)
NCT ID: NCT00547300
Last Updated: 2019-05-21
Results Overview
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
TERMINATED
PHASE3
49 participants
Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
2019-05-21
Participant Flow
Patient recruitment occurred over a four month period from October 2007 to January 2008 at 39 US sites.
All patients went through a 4 week hydrochlorothiazide (HCTZ) run-in phase before randomization.
Participant milestones
| Measure |
Nebivolol
Nebivolol 5 mg, 10 mg or 20 mg
|
Metoprolol Extended-Release (ER)
Metoprolol ER 50 mg, 100 mg or 200 mg
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
26
|
Reasons for withdrawal
| Measure |
Nebivolol
Nebivolol 5 mg, 10 mg or 20 mg
|
Metoprolol Extended-Release (ER)
Metoprolol ER 50 mg, 100 mg or 200 mg
|
|---|---|---|
|
Overall Study
Study was Administratively Terminated
|
25
|
24
|
|
Overall Study
Did not Meet Entry Criteria
|
0
|
2
|
Baseline Characteristics
Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
Baseline characteristics by cohort
| Measure |
Nebivolol
n=25 Participants
Nebivolol 5 mg, 10 mg or 20 mg
|
Metoprolol Extended-Release (ER)
n=24 Participants
Metoprolol ER 50 mg, 100 mg or 200 mg
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 9.32 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)Population: Formal analysis of the primary endpoint was not conducted in this abbreviated study as the study was terminated before visit 10 was reached.
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)Population: 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.
Outcome measures
Outcome data not reported
Adverse Events
Nebivolol
Metoprolol Extended-Release (ER)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nebivolol
n=25 participants at risk
Nebivolol 5 mg, 10 mg or 20 mg
|
Metoprolol Extended-Release (ER)
n=24 participants at risk；n=26 participants at risk
Metoprolol ER 50 mg, 100 mg or 200 mg
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
0.00%
0/24 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.0%
2/25 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
0.00%
0/24 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
4.2%
1/24 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
|
General disorders
Pain
|
8.0%
2/25 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
0.00%
0/24 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
8.3%
2/24 • Adverse Event data was collected over a four month period from October 2007 to January 2008.
Non-serious adverse events based on the safety population of (n=49).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER