HypertensionNASAANCT00999752
Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension
A study testing Nebivolol and Hydrochlorothiazide in people with Hypertension, run by InVasc Therapeutics, Inc. at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate the effects of Nebivolol and Hydrochlorothiazide on blood pressure in African Americans with high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Nebivolol and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to May 2010
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Known Hypertension by history
- Self-described African American
Who cannot join
- Uncontrolled Diabetes Mellitus (HbA1C>10)
- Known CAD, Cerebrovascular Disease, PVD or Renovascular Disease
- Liver disease
- Chronic Renal Disease
- Uncontrolled Hypertension (>199 systolic and/or >115)
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Vascular Research Foundation
Tucker, Georgia, 30084
About this study
Official title: A 25 Week, Open Label Study to Determine the Effects of Nebivolol When Added to Hydrochlorothiazide on Diastolic Function and Arterial Stiffness in African Americans With Hypertension
The main purpose of this study is to evaluate the effects of Nebivolol and Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.
Read the detailed description
Many blood pressure medications are not effective in African American men and women. The two lower chambers of the heart contract to pump blood to the body. The lower chambers have to relax so they can refill with blood to pump out again. Many patients with high blood pressure have stiffness in the lower chambers which prevents the heart from relaxing so it can properly fill with blood. Some patients with the stiffness in the lower chambers of the heart will develop heart failure.
The study is to test whether or not Nebivolol (Bystolic)and a diuretic Hydrochlorothiazide (HCTZ) will help the heart relax so the heart can properly fill and prevent stiffness of the lower heart chambers.
- Conditions
- Hypertension
- Being tested
- Nebivolol, Hydrochlorothiazide
- Keywords
- Hypertension, African Americans, Arterial Stiffness, Vascular Resistance
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
Also called Bystolic
5mg/day with increase to 10 mg/day to reach blood pressure <140/90
HydrochlorothiazideDrug
Also called HCTZ
Hydrochlorothiazide 25 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Nebivolol to reach blood pressure control Receives: Drug: Nebivolol |
| Arm B | Active comparator | Hydrochlorothiazide for blood pressure control Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90
Measured: Every visit for 25 weeks (9 study visits)
Secondary outcomes (1)
Differences after nebivolol treatment on diastolic function as measured by tissue doppler imaging (ECHO), arterial compliance and stiffness and vascular nitric oxide availability determined by neutrophil function
Measured: At the begining and end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
- Study completionMay 2010
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- InVasc Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bobby V Khan, MD PhD, Principal investigator, InVasc Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999752
- Sponsor's protocol ID
- AVR-2009-02 (BYS-MD-27)
- Acronym
- NASAA
- Status last verified
- May 2011
- First submitted
- 21 Oct 2009
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 25 Week, Open Label Study to Determine the Effects of Nebivolol When Added to Hydrochlorothiazide on Diastolic Function and Arterial Stiffness in African Americans With Hypertension
- ClinicalTrials.gov ID
- NCT00999752
- Acronym / sponsor ID
- NASAA / AVR-2009-02 (BYS-MD-27)
- Conditions
- Hypertension
- Keywords
- Hypertension, African Americans, Arterial Stiffness, Vascular Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- InVasc Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Oct 2009 (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 main purpose of this study is to evaluate the effects of Nebivolol and Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.
Detailed description
Many blood pressure medications are not effective in African American men and women. The two lower chambers of the heart contract to pump blood to the body. The lower chambers have to relax so they can refill with blood to pump out again. Many patients with high blood pressure have stiffness in the lower chambers which prevents the heart from relaxing so it can properly fill with blood. Some patients with the stiffness in the lower chambers of the heart will develop heart failure.
The study is to test whether or not Nebivolol (Bystolic)and a diuretic Hydrochlorothiazide (HCTZ) will help the heart relax so the heart can properly fill and prevent stiffness of the lower heart chambers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: NebivololNebivolol to reach blood pressure control |
| Arm B | Active comparator | Drug: HydrochlorothiazideHydrochlorothiazide for blood pressure control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Known Hypertension by history
- Self-described African American
Key exclusion criteria (5 listed)
- Uncontrolled Diabetes Mellitus (HbA1C>10)
- Known CAD, Cerebrovascular Disease, PVD or Renovascular Disease
- Liver disease
- Chronic Renal Disease
- Uncontrolled Hypertension (>199 systolic and/or >115)
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 |
|---|---|---|
| NebivololAlso: Bystolic5mg/day with increase to 10 mg/day to reach blood pressure <140/90 | Drug | Arm A |
| HydrochlorothiazideAlso: HCTZHydrochlorothiazide 25 mg/day | Drug | Arm B |
Primary outcome
Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90
Time frame: Every visit for 25 weeks (9 study visits)
1 secondary outcome
Differences after nebivolol treatment on diastolic function as measured by tissue doppler imaging (ECHO), arterial compliance and stiffness and vascular nitric oxide availability determined by neutrophil function
Time frame: At the begining and end of study
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 5 May 2011.
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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.
Bobby V Khan, MD PhD principal investigator
InVasc Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebivolol and Hydrochlorothiazide in people with Hypertension, run by InVasc Therapeutics, Inc. 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 2 inclusion and 5 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 5 May 2011. 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.
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?
Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90 (time frame: Every visit for 25 weeks (9 study visits)). 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 5 May 2011.