Trial Outcomes & Findings for A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients (NCT NCT00648895)
NCT ID: NCT00648895
Last Updated: 2010-09-20
Results Overview
Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
Before treatment and after 10 weeks
Results posted on
2010-09-20
Participant Flow
The recruitment period was from November 2007 to May 2009 at one US location.
All patients went through a 4-5 week, single blind, placebo washout phase before randomization.
Participant milestones
| Measure |
Nebivolol
A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
|
Metoprolol ER (TM)
A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Nebivolol
A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
|
Metoprolol ER (TM)
A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients
Baseline characteristics by cohort
| Measure |
Nebivolol
n=6 Participants
A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
|
Metoprolol ER (TM)
n=6 Participants
A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
|
Total
n=12 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
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
59.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before treatment and after 10 weeksPopulation: Due to the small sample size, no efficacy conclusion could be made. 0 measured value primary outcome =Not applicable.
Pre-and post-ischemia forearm vascular resistance (FVR), calculated by forearm blood flow (FBF) and systolic blood pressure (SBP), and assessed at the trough/pre-meal time point (used for percentage change analysis between baseline and postbaseline). Measurements occured at baseline (visit 5) and end of treatment (week 10).
Outcome measures
Outcome data not reported
Adverse Events
Nebivolol
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Metoprolol ER (TM)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nebivolol
n=6 participants at risk
A 6-week up-titration period (the dose of nebivolol was increased from 10 mg/d to a maximum of 40mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase
|
Metoprolol ER (TM)
n=6 participants at risk
A 6-week up-titration period (the dose of metoprolol ER was increased from 100 mg/d to a maximum of 400mg/d, if necessary, to achieve hypertension control) followed by a 4-week stable-dose period and a 2-week down-titration phase.
|
|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
16.7%
1/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Eye disorders
Cataract
|
16.7%
1/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
General disorders
Malaise
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
2/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
1/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
16.7%
1/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • 16 months
|
0.00%
0/6 • 16 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • 16 months
|
16.7%
1/6 • 16 months
|
Additional Information
John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism
Forest Laboratories
Phone: 1-201-427-8259
Email: [email protected]
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