CompletedNCT00648895Updated Sep 20, 2010Results posted

A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

A Phase 3 interventional study of Nebivolol and Metoprolol ER (TM) in Hypertension, sponsored by Forest Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2010-09-20.

Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years to 79 Years
Sex: All

Study summary

The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.

Conditions studied

Hypertension

Browse trials for

Hypertension 6,689

Keywords

Hypertension
Blood pressure
Nebivolol
Bystolic (TM)
Metoprolol ER (TM)

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 12 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female, ambulatory outpatients 18-79 years old at screening
Minimum 2-year history of Stage I/II hypertension
Qualifying blood pressure criteria for study entry and for randomization
Willing to adhere to the dietary compliance and undergo protocol procedures
Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Exclusion criteria

Exclusion Criteria:

Have any form of secondary hypertension
Have clinically significant respiratory or cardiovascular disease
Presence/history of coronary artery disease or peripheral vascular disease
Have diabetes mellitus, Type I or II
Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 12 participants (actual)

Study arms

Active comparator
1
Nebivolol
Drug: Nebivolol
Active comparator
2
Metoprolol ER (TM)
Drug: Metoprolol ER (TM)

Interventions

DrugNebivolol
nebivolol 10mg, 20mg, 40mg daily dosage, oral administration
Also known as: Bystolic (TM)
DrugMetoprolol ER (TM)
Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration
Also known as: Toprol XL (TM)

What researchers measure

Primary outcomes

Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).
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).
Time frame: Before treatment and after 10 weeks

Results

Posted Sep 20, 2010

Limitations and caveats

The study was terminated early because of difficulties with enrollment. Only 12 of 30 planned patients were enrolled.

Participant flow

The recruitment period was from November 2007 to May 2009 at one US location.

Participant flow — Overall Study
Milestone	Nebivolol	Metoprolol ER (TM)
Started	6	6
Completed	6	5
Not completed	0	1
Withdrew: Lack of efficacy	0	1

Outcome measures

PrimaryPercentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).

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).

Time frame:: Before treatment and after 10 weeks
Reported as:: Mean · Percentage

No measurements were reported for this outcome.

Adverse events

Collected over 16 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Nebivolol	—	0/6 (0%)	5/6 (83.3%)
Metoprolol ER (TM)	—	0/6 (0%)	5/6 (83.3%)

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	Nebivolol	Metoprolol ER (TM)
NasopharyngitisInfections and infestations	2/6	0/6
Back painMusculoskeletal and connective tissue disorders	2/6	1/6
HypoacusisEar and labyrinth disorders	1/6	0/6
CataractEye disorders	1/6	0/6
Abdominal discomfortGastrointestinal disorders	1/6	0/6
DiarrhoeaGastrointestinal disorders	0/6	1/6
GastritisGastrointestinal disorders	0/6	1/6
NauseaGastrointestinal disorders	0/6	1/6
ToothacheGastrointestinal disorders	0/6	1/6
MalaiseGeneral disorders	0/6	1/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Nebivolol	Metoprolol ER (TM)	Total
<=18 years	0	0	0
Between 18 and 65 years	4	1	5
>=65 years	2	5	7

Age Continuous
Age Continuous(years)	Nebivolol	Metoprolol ER (TM)	Total
Mean	59.5 ± 5.8	67.3 ± 11.6	63.4 ± 9.7

Sex: Female, Male
Sex: Female, Male(Participants)	Nebivolol	Metoprolol ER (TM)	Total
Female	2	0	2
Male	4	6	10

Region of Enrollment
Region of Enrollment(participants)	Nebivolol	Metoprolol ER (TM)	Total
United States	6	6	12

Study locations

1 site

Forest Investigative Site
Houston, Texas 77030, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00648895
Lead sponsor: Forest Laboratories
First posted: Apr 1, 2008
Start date: Nov 2007
Primary completion: Jul 2009
Results posted: Sep 20, 2010
Last update: Sep 20, 2010

Study contacts

Tatjana Lukic, MD., M.Sc.

study director · Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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