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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_020 |
Not provided
Not provided
Not provided
Study terminated early due to sample size, not possible to perform further statistical analysis.
Not provided
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Evaluate pleiotropic effects of simvastatin in hypertensive patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan 80 mg + Paravastin 40 mg | Active Comparator | Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A) |
|
| Valsartan 80 mg + Simvastatin 40 mg | Active Comparator | Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B) |
|
| Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | Experimental | Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C) |
|
| Valsartan 80 mg | Active Comparator | Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug | 80 mg valsartan. Duration: 12 months. Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients | Left ventricular hypertrophy reduction was to be measured by echocardiography. | 6 Month(s) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Valsartan 80 mg + Paravastin 40 mg | Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A) |
| FG001 | Valsartan 80 mg + Simvastatin 40 mg | Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B) |
| FG002 | Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C) |
| FG003 | Valsartan 80 mg | Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Valsartan 80 mg + Paravastin 40 mg | Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A) |
| BG001 | Valsartan 80 mg + Simvastatin 40 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients | Left ventricular hypertrophy reduction was to be measured by echocardiography. | This study was terminated early and due to sample size it was not possible to perform further statistical analyses. | Posted | 6 Month(s) |
|
Not provided
Not provided
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 | Valsartan 80 mg + Paravastin 40 mg | Participants who were administered Valsartan 80 mg plus paravastin 40 mg by mouth daily for one year. (Group A) |
Not provided
Not provided
This study was terminated early and due to sample size it was not possible to perform further statistical analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D017035 | Pravastatin |
| D019821 | Simvastatin |
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| pravastatin | Drug | 40 mg pravastatin. Duration: 12 months. Tablets |
|
|
| simvastatin | Drug | 40 mg simvastatin. Duration: 12 months. Tablets |
|
|
| ezetimibe (+) simvastatin | Drug | ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets |
|
|
Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B)
| BG002 | Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C) |
| BG003 | Valsartan 80 mg | Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C) |
| OG003 | Valsartan 80 mg | Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) |
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Valsartan 80 mg + Simvastatin 40 mg | Participants who were administered Valsartan 80 mg plus simvastatin 40 mg by mouth daily for one year. (Group B) | 0 | 3 | 0 | 3 |
| EG002 | Valsartan 80 mg + Simvastatin 40 mg / Ezetimibe 10 mg | Participants who were administered Valsartan 80 mg plus simvastatin 40 mg / ezetimibe 10 mg by mouth daily for one year. (Group C) | 0 | 3 | 0 | 3 |
| EG003 | Valsartan 80 mg | Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D) | 0 | 2 | 0 | 2 |
Not provided
Not provided
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D008148 | Lovastatin |
| D000069438 | Ezetimibe |
| D001384 | Azetidines |
| D001385 | Azetines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |