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| ID | Type | Description | Link |
|---|---|---|---|
| 20090713 | Other Identifier | UConn Health Center |
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Administrative/Sponsor Business Decision - terminated - study was not completed
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.
This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin D deficiency. Additionally, this study will further explore the potential additional effects of adding vitamin D to aliskiren in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: Aliskiren | Active Comparator | Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Aliskiren 150 mg to 300 mg once daily for 6 weeks |
|
| Phase I: Cholecalciferol | Active Comparator | Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks |
|
| Phase II: Aliskiren and Vitamin D3 | Active Comparator | Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | 150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ambulatory Diastolic Blood Pressure | The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency. | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William B White, M.D. | Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
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Study initiated in 2010, study terminated prematurely by the sponsor in December 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aliskiren and Vitamin D3 AND Aliskiren Versus Vitamin D3 | Study stopped prematurely. Intervention groups combined because data were never unblinded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Group assignment was blinded to the PI and was never unblinded due to the discontinuation of the study by the sponsor. Therefore we are unable to determine the number of participants in each group. No data analyses occurred due to lack of any scientific utility of the information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3 | Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks. Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data not analyzed by groups as group assignment was blinded (and never un-blinded due to discontinuation by the sponsor). There were 30 participants between 18 and 65 years, and 10 participants over 65 years. |
| 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 From Baseline in Ambulatory Diastolic Blood Pressure | The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency. | Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility. | Posted | six weeks |
|
Adverse event data were collected throughout the duration of the study ~ 2 years, 6 months
Data not analyzed by groups as group assignment was blinded (and never un-blinded due to discontinuation by the sponsor).
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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 Versus Vitamin D3 AND Aliskiren and Vitamin D3 | Phase I: Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks. Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks. |
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Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William White | UCHC | 860-679-2104 | wwhite@uchc.edu |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Cholecalciferol | Dietary Supplement | 3000 I.U. once daily for 6 weeks |
|
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| Placebo | Dietary Supplement | Placebo for two weeks |
|
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Data not analyzed by groups as group assignment was blinded (and never un-blinded due to discontinuation by the sponsor). There were 25 females and 15 males in total randomized to the study. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP. | Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility. | Posted | 6 weeks |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |