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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0954A-366 |
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This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period of at least three months on serum uric acid levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum Uric Acid (SUA) Level | SUA at baseline and Month 3. | Baseline and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients With Hyperuricemia | Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males. | Baseline and Month 3 |
| Diastolic Blood Pressure (DBP) | DBP at baseline and month 3. |
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Inclusion criteria:
Participant was >20 years and <75 years of age on the index date (i.e., the date of initiating MK-0954A therapy)
Diagnosed with hypertension and had received MK-0954A 50/12.5 mg for at least 3 months
Had at least one serum uric acid measurements at baseline and one at 3 months after using MK-0954A 50/12.5 mg
Had the following records documented in the chart during the data collection period:
Exclusion criteria:
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Data from 33 physicians from different levels of hospitals were invited to provide information on patients who received MK-0954A and had pre- and post-treatment serum uric acid and lipid profile reports during the study period. Each physician could provide up to 30 clinical charts of patients matching the inclusion criteria for the study.
1735 patients were enrolled into this study. Among them, 1705 patients were eligible after excluding 30 patients.
All the medical charts of the eligible study patients were reviewed. The study index period (when patients had to have received treatment for 3 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively between November 2008 and August 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months |
| 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 | Serum Uric Acid (SUA) Level | SUA at baseline and Month 3. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Month 3 |
|
|
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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 | All Participants | Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline and Month 3 |
| Systolic Blood Pressure (SBP) | SBP at baseline and month 3. | Baseline and Month 3 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
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| Secondary | The Percentage of Patients With Hyperuricemia | Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males. | Posted | Number | percent of participants | Baseline and Month 3 |
|
|
|
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| Secondary | Diastolic Blood Pressure (DBP) | DBP at baseline and month 3. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 3 |
|
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| Secondary | Systolic Blood Pressure (SBP) | SBP at baseline and month 3. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 3 |
|
|
|
|
| 0 |
| 1,705 |
| 7 |
| 1,705 |
| Tachycardia/Palpitation | Cardiac disorders |
|
| Dyspnea with wheezing | Respiratory, thoracic and mediastinal disorders |
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| Mild cough | Respiratory, thoracic and mediastinal disorders |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.