HypertensionPhase 1NCT00158093
A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo
A Phase 1 study testing Nebivolol, Atenolol and Moxifloxacin in people with Hypertension, run by Mylan Bertek Pharmaceuticals at 1 site in United States.
Trial summary
Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Nebivolol, Atenolol and Moxifloxacin
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Jul 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and nonpregnant, nonlactating women were 18 years or older.
- Women declaring postmenopausal or surgical sterility.
- Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.
- Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).
Who cannot join
- Institutionalized
- Reported or was known to have done the following:
- Used any tobacco product.
- Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication
- Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication.
- Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication.
Show all 18Show fewer
- Recently changed dietary or exercise habits significantly
- Used any medication (including over-the-counter [OTC]) within the 14 days prior to the initial dose of study medication.
- Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- Received an investigational drug within 30 days prior to the initial dose of study medication.
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
- History of drug and/or alcohol abuse within 1 year prior to the study.
- Acute illness at the time of either the pre study medical evaluation or dosing.
- Any laboratory results deemed clinically significant by the physician.
- Abnormal and clinically relevant ECG tracing.
- Donated or lost a significant volume of blood or plasma (>450 mL) within 28 days prior to the initial dose of study medication.
- Allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics.
- History of seizures or cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel Group Safety Evaluation of Electrocardiographic Intervals and Blood Pressure in Normal Healthy Volunteers After Nebivolol, Atenolol, Moxifloxacin, or Placebo Administration After Single and Repeated Doses
Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.
- Conditions
- Hypertension
- Being tested
- Nebivolol, Atenolol, Moxifloxacin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
AtenololDrug
MoxifloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.
Secondary outcomes (1)
The secondary endpoints were the change in average QTc intervals from Day 0 to all other evaluation times and the change in other ECG intervals (PR, RR, QRS, QT) and HR from Day 0 to all other evaluation times.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants
Sponsor and investigators
- Lead sponsor
- Mylan Bertek Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lawrence A Galitz, MD, Principal investigator, SFBC InternationalWill A Sullivan, BS, Study director, Mylan Bertek Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158093
- Sponsor's protocol ID
- NEB122
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group Safety Evaluation of Electrocardiographic Intervals and Blood Pressure in Normal Healthy Volunteers After Nebivolol, Atenolol, Moxifloxacin, or Placebo Administration After Single and Repeated Doses
- ClinicalTrials.gov ID
- NCT00158093
- Acronym / sponsor ID
- NEB122
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants
- Lead sponsor
- Mylan Bertek PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Jul 2003
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and nonpregnant, nonlactating women were 18 years or older.
- Women declaring postmenopausal or surgical sterility.
- Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.
- Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).
Key exclusion criteria (18 listed)
- Institutionalized
- Reported or was known to have done the following:
- Used any medication (including over-the-counter [OTC]) within the 14 days prior to the initial dose of study medication.
- Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- Received an investigational drug within 30 days prior to the initial dose of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebivolol | Drug | – |
| Atenolol | Drug | – |
| Moxifloxacin | Drug | – |
Primary outcome
The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.
1 secondary outcome
The secondary endpoints were the change in average QTc intervals from Day 0 to all other evaluation times and the change in other ECG intervals (PR, RR, QRS, QT) and HR from Day 0 to all other evaluation times.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence A Galitz, MD principal investigator
SFBC International
Will A Sullivan, BS study director
Mylan Bertek Pharmaceuticals Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nebivolol, Atenolol and Moxifloxacin in people with Hypertension, run by Mylan Bertek Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2005.