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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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To determine whether addition of Carvedilol CR to diabetic patients with hypertension who are receiving the ACEi,Lisinopril,will provide added benefits to blood vessels when compared to treatment with Lisinopril alone.It is believed that carvedilol provides added benefits by suppressing free radicals(charged substances that cause damage to the body ) and inflammation.
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress.Both vascular oxidative stress and inflammation are CVD risk factors and impact endothelial function.
Carvedilol has been demonstrated in preclinical and clinical studies (although limited in size) to exert anti-inflammatory and antioxidant properties: (1) reduce the inflammation markers such as high sensitivity C-reactive protein (hsCRP); (2) reduce oxidative stress via dually eliminating existing reactive oxygen species (ROS) and suppressing the generation of ROS; (3) prevent lipid peroxidation in myocardial cell membrane; (4) protect endothelial and vascular muscle cells from oxygen radical-mediated injury.
This project is about studying the effect of carvedilol CR on blood vessels of diabetic hypertensive patients as compared to Lisinopril alone.
This study involves weaning patient off their current antihypertensive medications and starting them on Lisinopril with Carvedilol CR or lisinopril alone for 6 months and studying the effects of the drugs during this period and thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carvedilol | Experimental | carvedilol |
|
| lisinopril | Active Comparator | lisinopril |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol Controlled Release (CR) | Drug | lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study. Initial dose: Carvedilol CR (20 mg QD, dose level 1) Titration: If tolerated, increase the dosage to 20 mg QD, 40 mg QD, and 80mg QD orally over successive intervals of at least 2 weeks to achieve target blood pressure sSBP <130 and sDBP < 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brachial Artery Vascular Reactivity | Percent change from baseline in Brachial artery vascular reactivity at 6 months calculated as: (brachial reactivity at 6 months-brachial reactivity at 0 months)/brachial reactivity at 0 month *100 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxidative Stress in Mononuclear Cells (MNC) | Percent change from baseline in Reactive Oxygen species (ROS) generation in MNC at 6 months calculated as: (ROS at 6 months-ROS at 0 months)/ROS at 0 month *100 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paresh Dandona, MD, PhD | Kaleida Health / University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes - Endocrinology Center of Western New York | Buffalo | New York | 14221 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carvedilol | carvedilol Experimental arm carvedilol CR (controlled release) added to Lisinopril Doses titrated to maintain optimal blood pressure. |
| FG001 | Lisinopril | lisinopril control arm Lisinopril dose titrated to maintain optimal blood pressure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carvedilol | carvedilol carvedilol: carvedilol |
| BG001 | Lisinopril | lisinopril lisinopril: lisinopril |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Brachial Artery Vascular Reactivity | Percent change from baseline in Brachial artery vascular reactivity at 6 months calculated as: (brachial reactivity at 6 months-brachial reactivity at 0 months)/brachial reactivity at 0 month *100 | Posted | Mean | Standard Error | percentage of change | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carvedilol | carvedilol carvedilol: carvedilol | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paresh Dandona | State University of NY at Buffalo | 7165351852 | dandona@buffalo.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
|
| lisinopril | Drug | lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | Kg/m^2 |
|
| systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Oxidative Stress in Mononuclear Cells (MNC) | Percent change from baseline in Reactive Oxygen species (ROS) generation in MNC at 6 months calculated as: (ROS at 6 months-ROS at 0 months)/ROS at 0 month *100 | Posted | Mean | Standard Error | percentage of change | 6 months |
|
|
|
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Lisinopril | lisinopril lisinopril: lisinopril | 0 | 7 | 0 | 7 | 0 | 7 |
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| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |