HypertensionPhase 3NCT00200499
A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients
A Phase 3 study testing Nebivolol in people with Hypertension, run by Mylan Bertek Pharmaceuticals at 1 site in United States.
Trial summary
The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Nebivolol
- How many people
- 845 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Sep 2003
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.
Who cannot join
- Secondary hypertension
- myocardial infarction or stroke
- contraindications to beta-blocker therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mylan Pharmaceuticals Inc.
Morgantown, West Virginia, 26505
About this study
Official title: A Multi-Center, Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients With Mild to Moderate Hypertension
The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.
Read the detailed description
This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated, based on entry into NEB 202, NEB 302 or NEB 305). Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist. After successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study. Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.
- Conditions
- Hypertension
- Being tested
- Nebivolol
- Keywords
- Nebivolol, Hypertension, Beta-Blocker
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.
Secondary outcomes (8)
Change in the average
- sitting systolic blood pressure
- supine and standing systolic and diastolic blood pressure
- response rate of treatment groups
- AEs
- ECGs
- laboratory parameters
- heart rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2002
- Study completionSep 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 845 participants
Sponsor and investigators
- Lead sponsor
- Mylan Bertek Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Betty S. Riggs, MD, MBA, Study director, Mylan Pharmaceuticals Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200499
- Sponsor's protocol ID
- NEB306
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 16 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients With Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT00200499
- Acronym / sponsor ID
- NEB306
- Conditions
- Hypertension
- Keywords
- Nebivolol, Hypertension, Beta-Blocker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 845 participants
- Lead sponsor
- Mylan Bertek PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Study completion
- Sep 2003
- First posted
- 20 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.
The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.
Detailed description
This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated, based on entry into NEB 202, NEB 302 or NEB 305). Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist. After successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study. Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.
Key exclusion criteria (3 listed)
- Secondary hypertension
- myocardial infarction or stroke
- contraindications to beta-blocker therapy
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 | – |
Primary outcome
The change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.
8 secondary outcomes
Change in the average
- sitting systolic blood pressure
- supine and standing systolic and diastolic blood pressure
- response rate of treatment groups
- AEs
- ECGs
- laboratory parameters
- heart rate
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 16 Dec 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.
Betty S. Riggs, MD, MBA study director
Mylan 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 3 study testing Nebivolol 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 1 inclusion and 3 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 16 Dec 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.. 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 16 Dec 2005.