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Sponsor requested termination.
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.
Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aliskiren 300 mg once daily for 12 weeks | Active Comparator | aliskiren 300 mg daily |
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| Sugar pill/ placebo | Placebo Comparator | Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren 300 mg once daily | Drug | aliskiren 300 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Flow-mediated Dilation | Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Central Aortic Pressure at 3 Months | Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor) | 3 months after start of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Calhoun, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren | aliskiren 300 mg daily |
| FG001 | Sugar Pill/Placebo | Sugar pill/placebo arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo/sugar pill | Drug | Sugar pill/placebo |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren | aliskiren 300 mg daily |
| BG001 | Placebo | Sugar pill/placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Flow-mediated Dilation | Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion | Posted | Mean | Standard Deviation | percentage of flow-mediated dilation | Baseline to 3 months |
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| Secondary | Mean Central Aortic Pressure at 3 Months | Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor) | Aortic pressure indicates the augmentation pressure (AP) in mmHg derived from the radial artery waveform. | Posted | Mean | Standard Deviation | mm Hg | 3 months after start of study |
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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 | Aliskiren | aliskiren 300 mg daily | 0 | 10 | 0 | 10 | ||
| EG001 | Placebo | Sugar pill/ placebo | 0 | 11 | 0 | 11 |
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Early termination leading to smaller number of subjects analyzed then anticipated, no adverse effects within the aliskiren group
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David A. Calhoun, MD | University of Alabama at Birmingham | 205-934-4633 | dcalhoun@uab.edu |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D058246 | Prehypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| >=65 years |
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| Male |
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