High Blood PressurePhase 2/3NCT01939990
Safety Study of Nebivolol for COPD Patients
A Phase 2/3 study testing Nebivolol in people with High Blood Pressure, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the safety and effectiveness of the study drug Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Nebivolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2013
- Phase
- Phase 2/3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of high blood pressure and chronic obstructive pulmonary disease (COPD)
Who cannot join
- Asthma; Heart failur;
- End stage kidney disease;
- acute myocardial infarction,unstable angina, stroke or TIA within the past year;
- Females who are pregnant, lactating or women of childbearing potential who are not using approved method of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Nebivolol in Chronic Obstructive Pulmonary Disease
The purpose of this study is to demonstrate the safety and effectiveness of the study drug Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
The study would be a randomized, placebo-controlled trial of 60 hypertensive patients with documented COPD greater than age 40.
- Conditions
- High Blood Pressure
- Being tested
- Placebo, Nebivolol
- Keywords
- Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Hypertension, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo is a sugar pill.
The placebo looks like the study drug but it does not contain active ingredients.
NebivololDrug
Also called bystolic
5 to 10mg per day
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol | Active comparator | Group A will be given Nebivolol 5 to 10mg per day Receives: Drug: Nebivolol |
| Placebo | Placebo comparator | Group B will be given Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess blood pressure control
blood pressure control will be assessed per collection of research data at protocol visits.
Measured: baseline to 4 weeks
Secondary outcomes (1)
to assess pulmonary function tests
pulmonary function tests will be assessed at protocol visits
Measured: baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Funding was discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- George Bakris, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939990
- Sponsor's protocol ID
- 11-0720
- Status last verified
- Jan 2016
- First submitted
- 22 Jan 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebivolol in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01939990
- Acronym / sponsor ID
- 11-0720
- Conditions
- High Blood Pressure
- Keywords
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was discontinued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Sep 2013 (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 purpose of this study is to demonstrate the safety and effectiveness of the study drug Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
The study would be a randomized, placebo-controlled trial of 60 hypertensive patients with documented COPD greater than age 40.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebivolol | Active comparator | Drug: NebivololGroup A will be given Nebivolol 5 to 10mg per day |
| Placebo | Placebo comparator | Drug: PlaceboGroup B will be given Placebo. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of high blood pressure and chronic obstructive pulmonary disease (COPD)
Key exclusion criteria (4 listed)
- Asthma; Heart failur;
- End stage kidney disease;
- acute myocardial infarction,unstable angina, stroke or TIA within the past year;
- Females who are pregnant, lactating or women of childbearing potential who are not using approved method of contraception.
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 |
|---|---|---|
| PlaceboAlso: Placebo is a sugar pill.The placebo looks like the study drug but it does not contain active ingredients. | Drug | Placebo |
| NebivololAlso: bystolic5 to 10mg per day | Drug | Nebivolol |
Primary outcome
to assess blood pressure control
Time frame: baseline to 4 weeks
blood pressure control will be assessed per collection of research data at protocol visits.
1 secondary outcome
to assess pulmonary function tests
Time frame: baseline to 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- clinical trials at the University of ChicagoLink provided by the sponsor.
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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.
George Bakris, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nebivolol in people with High Blood Pressure, run by University of Chicago 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 4 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: withdrawn, as of the sponsor's last update on 12 Jan 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
to assess blood pressure control (time frame: baseline to 4 weeks). 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 Jan 2016.