Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension (NASAA)
This study has been completed.
Sponsor:
InVasc Therapeutics, Inc.
Information provided by:
InVasc Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00999752
First received: October 21, 2009
Last updated: May 4, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension |
Drug: Nebivolol Drug: Hydrochlorothiazide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Further study details as provided by InVasc Therapeutics, Inc.:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm A
Nebivolol to reach blood pressure control
|
Drug: Nebivolol
5mg/day with increase to 10 mg/day to reach blood pressure <140/90
Other Name: Bystolic
|
|
Active Comparator: Arm B
Hydrochlorothiazide for blood pressure control
|
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25 mg/day
Other Name: HCTZ
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Known Hypertension by history
- Self-described African American
Exclusion Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999752
Locations
| United States, Georgia | |
| Atlanta Vascular Research Foundation | |
| Tucker, Georgia, United States, 30084 | |
Sponsors and Collaborators
InVasc Therapeutics, Inc.
Investigators
| Principal Investigator: | Bobby V Khan, MD PhD | InVasc Therapeutics, Inc. |
More Information
No publications provided
| Responsible Party: | Bobby V. Khan, MD PhD, InVasc Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00999752 History of Changes |
| Other Study ID Numbers: | AVR-2009-02 (BYS-MD-27) |
| Study First Received: | October 21, 2009 |
| Last Updated: | May 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by InVasc Therapeutics, Inc.:
|
Hypertension African Americans Arterial Stiffness Vascular Resistance |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Nebivolol Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Vasodilator Agents Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013