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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL105440 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The investigators hypothesize that, among non-hypertensive overweight and obese individuals, treatment of vitamin D deficiency and lowering uric acid concentrations (by either xanthine oxidase inhibition or increased renal excretion) will attenuate renin angiotensin system (RAS) activation, improve endothelial function, and lower blood pressure.
We have demonstrated that lower levels of 25-hydroxyvitamin D (25[OH]D) and higher concentrations of uric acid are both potentially modifiable factors that are independently associated with an increased risk of developing hypertension (high blood pressure) in humans. Other investigators have shown that vitamin D supplementation, or lowering uric acid with allopurinol, may reduce blood pressure. Animal experiments suggest that activation of both the systemic and local kidney-specific renin angiotensin systems (RAS) may be the principal mechanism linking 25(OH)D and uric acid with hypertension. In human parallels to these animal studies, we have shown in cross-sectional analyses that non-hypertensive individuals with lower 25(OH)D and higher uric acid levels have increased activation of their systemic and kidney-specific RAS, independent of other factors. However, whether vitamin D supplementation or uric acid lowering attenuates RAS activation has never been demonstrated in humans. Both lower 25(OH)D and higher uric acid concentrations are also associated with endothelial dysfunction in humans, and endothelial function may modulate the RAS and provide an alternate mechanism for the development of hypertension. It remains unclear, however, whether an intervention to increase 25(OH)D or decrease uric acid levels among non-hypertensive adults improves endothelial function; furthermore, it is unknown whether treatment of these individuals would lower blood pressure. Determining whether treatment of 25(OH)D and uric acid concentrations, per se, can attenuate RAS activation, improve endothelial function, and lower blood pressure among nonhypertensive individuals is critically important, with implications stretching beyond hypertension prevention, since RAS activation, endothelial dysfunction, and blood pressure are also implicated in the pathology of cardiovascular and chronic kidney disease. Individuals who are overweight and obese (two-thirds of US adults) represent an important population who are known to have lower 25(OH)D levels, higher uric acid concentrations, activation of the RAS, endothelial dysfunction, and an increased risk of hypertension, cardiovascular disease, and chronic kidney disease. Interestingly, our preliminary data demonstrate that among overweight and obese individuals with normal 25(OH)D or low uric acid levels, adiposity is no longer associated with activation of the RAS, suggesting that low 25(OH)D and high uric acid concentrations might be mediators of the adverse consequences of overweight and obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks. |
|
| Probenecid | Experimental | Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total). |
|
| Allopurinol | Experimental | Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total). |
|
| Placebo- Vitamin D | Placebo Comparator | Placebo soft gel once per week for 8 weeks. |
|
| Placebo- Uric Acid | Placebo Comparator | Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D ergocalciferol | Drug | 50,000 unit soft gel capsule once per week for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D] | Change in RPF in response to captopril is a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF. | Week 8 (pre and post captopril) |
| Plasma Renin Activity (PRA) [Vitamin D] | PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test. | Week 8 |
| Angiotensin II (ATII) Concentration [Vitamin D] | ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test. | Week 8 |
| Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid] | RPF in response to captopril iis a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endothelium-Dependent Vasodilation (EDV) | Endothelial function was assessed by EDV using brachial artery ultrasonography. Measurements of brachial artery diameter were made under basal conditions and reactive hyperemia following ischaemic stimulus. A blood pressure cuff on the forearm was pumped up for 5 minutes then released. Images were taken at baseline and after reactive hyperemia (increased blood flow). The maximum diameter was determined by the investigator. Change in EDV was expressed as a percent of brachial luminal diameter calculated as post-ischaemic brachial artery diameter - pre-ischaemic brachial artery diameter/pre-ischaemic brachial artery diameter * 100. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Forman, MD, MSc | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks. |
| FG001 | Placebo- Vitamin D | Placebo soft gel once per week for 8 weeks. |
| FG002 | Probenecid | Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total). |
| FG003 | Allopurinol | Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total). |
| FG004 | Placebo- Uric Acid | Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks. |
| BG001 | Placebo- Vitamin D | Placebo soft gel once per week for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All randomized participants in the Vitamin D arms. |
| 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 Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D] | Change in RPF in response to captopril is a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF. | All randomized enrolled participants included in the analysis. | Posted | Mean | Standard Deviation | mL/min per 1.73 m^2 | Week 8 (pre and post captopril) |
Not provided
All randomized participants who received study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D | Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John P Forman, MD | Brigham and Women's Hospital | jforman@partners.org |
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D014807 | Vitamin D |
| D011339 | Probenecid |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Probenecid | Drug | 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total) |
|
| Allopurinol | Drug | 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total) |
|
| Placebo | Drug | Placebo soft gel once per week for 8 weeks |
|
| Placebo | Drug | Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total) |
|
| Week 8 (pre and post captopril) |
| Plasma Renin Activity (PRA) [Uric Acid] | PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test. | Week 8 |
| Angiotensin II (ATII) Concentration [Uric Acid] | ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test. | Week 8 |
| Baseline and Week 8 (pre and post ischaemic stimulus) |
| Mean 24-Hour Ambulatory Blood Pressure (ABP) | A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. | Baseline and Week 8 |
| Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping | A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. Nocturnal dipping is the percent change lower between the daytime and nighttime values. | Baseline and Week 8 |
| Lost to Follow-up |
|
| Not Available for the 8 Week Visit |
|
| Participant Developed a Rash |
|
| Non-compliant with Medication |
|
| Adverse Event |
|
| Not Compliant with Study Procedures |
|
| Pregnancy |
|
| Started an Exclusionary Medication |
|
| Withdrew due to Health Condition |
|
| BG002 | Probenecid | Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total). |
| BG003 | Allopurinol | Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total). |
| BG004 | Placebo- Uric Acid | Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total). |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | All randomized participants. | All randomized participants in the Uric Acid arms. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Change in Renal Plasma Flow (RPF) in Response to Captopril [Vitamin D] | An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF. | All randomized participants in the Vitamin D arms with data available for RPF. | Mean | Standard Deviation | milliliters(mL)/minute(min) per 1.73 m^2 |
|
| Change in RPF in Response to Captopril [Uric Acid] | An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF. | All randomized participants in the Uric Acid arms with data available for RPF. | Mean | Standard Deviation | mL/min per 1.73 m^2 |
|
| Plasma Renin Activity (PRA) [Vitamin D] | All randomized participants in the Vitamin D arms with data available for PRA. | Mean | Standard Deviation | nanograms (ng)/mL per hour |
|
| Plasma Renin Activity (PRA) [Uric Acid] | All randomized participants in the Uric Acid arms with data available for PRA. | Mean | Standard Deviation | ng/mL |
|
| Angiotensin II Concentration (ATII) [Vitamin D] | All randomized participants in the Vitamin D arms with data available for ATII. | Mean | Standard Deviation | picogram(pg)/mL |
|
| Angiotensin II Concentration (ATII) [Uric Acid] | All randomized participants in the Uric Acid arms with data available for ATII. | Mean | Standard Deviation | pg/mL |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Vitamin D | Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks. |
| OG001 | Placebo- Vitamin D | Placebo soft gel once per week for 8 weeks. |
|
|
|
| Primary | Plasma Renin Activity (PRA) [Vitamin D] | PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test. | All randomized enrolled participants included in the analysis. | Posted | Mean | Standard Deviation | ng/mL per hour | Week 8 |
|
|
|
|
| Primary | Angiotensin II (ATII) Concentration [Vitamin D] | ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test. | All randomized enrolled participants included in the analysis. | Posted | Mean | Standard Deviation | pg/mL | Week 8 |
|
|
|
|
| Primary | Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid] | RPF in response to captopril iis a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF. | All randomized enrolled participants with data available for analysis. | Posted | Median | Inter-Quartile Range | mL/min per 1.73 m^2 | Week 8 (pre and post captopril) |
|
|
|
|
| Primary | Plasma Renin Activity (PRA) [Uric Acid] | PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test. | All randomized enrolled participants with data available for analysis. | Posted | Median | Inter-Quartile Range | ng/mL per hour | Week 8 |
|
|
|
|
| Primary | Angiotensin II (ATII) Concentration [Uric Acid] | ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test. | All randomized enrolled participants with data available for analysis. | Posted | Median | Inter-Quartile Range | pg/mL | Week 8 |
|
|
|
|
| Secondary | Change in Endothelium-Dependent Vasodilation (EDV) | Endothelial function was assessed by EDV using brachial artery ultrasonography. Measurements of brachial artery diameter were made under basal conditions and reactive hyperemia following ischaemic stimulus. A blood pressure cuff on the forearm was pumped up for 5 minutes then released. Images were taken at baseline and after reactive hyperemia (increased blood flow). The maximum diameter was determined by the investigator. Change in EDV was expressed as a percent of brachial luminal diameter calculated as post-ischaemic brachial artery diameter - pre-ischaemic brachial artery diameter/pre-ischaemic brachial artery diameter * 100. | All randomized enrolled participants. | Posted | Mean | Standard Deviation | percent of brachial luminal diameter | Baseline and Week 8 (pre and post ischaemic stimulus) |
|
|
|
|
| Secondary | Mean 24-Hour Ambulatory Blood Pressure (ABP) | A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. | All randomized enrolled participants with complete 24-hour ABP data available for analysis. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 8 |
|
|
|
|
| Secondary | Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping | A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. Nocturnal dipping is the percent change lower between the daytime and nighttime values. | All randomized enrolled participants with complete 24-hour ABP data available for analysis. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 8 |
|
|
|
|
| 0 |
| 43 |
| 5 |
| 43 |
| EG001 | Placebo- Vitamin D | Placebo soft gel once per week for 8 weeks. | 0 | 45 | 6 | 45 |
| EG002 | Probenecid | Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total). | 4 | 46 | 16 | 46 |
| EG003 | Allopurinol | Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total). | 6 | 48 | 36 | 48 |
| EG004 | Placebo- Uric Acid | Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total). | 2 | 51 | 25 | 51 |
| Elevated creatinine | Investigations | Systematic Assessment |
|
| Elevated liver enzymes | Investigations | Systematic Assessment |
|
| Decreased hematocrit | Investigations | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated phosphorus | Investigations | Systematic Assessment |
|
| Elevated potassium | Investigations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Flushing | Vascular disorders | Systematic Assessment |
|
| Tingling in extremities | General disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Altered taste | General disorders | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Transient shortness of breath | General disorders | Systematic Assessment |
|
| Transient nose bleed | General disorders | Systematic Assessment |
|
| Transient facial swelling | General disorders | Systematic Assessment |
|
| Unusual reaction to bee sting | General disorders | Systematic Assessment |
|
| Sleepiness | Nervous system disorders | Systematic Assessment |
|
| Difficulty sleeping | Nervous system disorders | Systematic Assessment |
|
| Sensitivity to touch | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Superiority |
| Superiority |
| Superiority |
| Week 8 |
|
| 0.7 |
Statistical significance was set for a 2-tailed P <0.05. |
| Superiority |
| Week 8 | t-test, 2 sided | 0.06 | Statistical significance was set for a 2-tailed P <0.05. | Superiority |
| Overall Diastolic Blood Pressure (DBP), Baseline |
|
| Awake SBP, Baseline |
|
| Asleep SBP, Baseline |
|
| Overall SBP, Week 8 |
|
| Overall DBP, Week 8 |
|
| Awake SBP, Week 8 |
|
| Asleep SBP, Week 8 |
|
| 0.64 |
Statistical significance was set for P>0.05. |
| Superiority |
| Awake SBP | Repeated Measures Analysis | 0.80 | Statistical significance was set for P>0.05. | Superiority |
| Asleep SBP at Week 8 | Repeated Measures Analysis | 0.97 | Statistical significance was set for P>0.05. | Superiority |
| Overall SBP | Repeated Measures Analysis | 0.34 | Superiority |
| Overall DBP | Repeated Measures Analysi | 0.59 | Superiority |
| Awake SBF | Repeated Measures Analysis | 0.57 | Superiority |
| Asleep SBP | Repeated Measures Analysis | 0.08 | Superiority |
| Overall SBP | Repeated Measures Analysis | 0.59 | Superiority |
| Repeated Measures Analysis | 0.53 | Superiority |
| Awake SBP | Repeated Measures Analysis | 0.55 | Superiority |
| Asleep SBP | Repeated Measures Analysis | 0.80 | Superiority |
| Week 8 |
|
| Superiority |
| Repeated Measures Analysis | 0.97 | Superiority |