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| ID | Type | Description | Link |
|---|---|---|---|
| MK0954A-331 | |||
| 2007_030 |
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To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Losartan (MK0954) / Losartan + HCTZ (MK0954A) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan potassium (+) hydrochlorothiazide | Drug | All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c Between 52 Weeks and Baseline | Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value. | 52 Weeks - Baseline |
| Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments | Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments. | 52 Weeks - Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Target Blood Pressure | Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks | 52 Weeks |
| Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Waist Circumference Between Baseline and 52 Week Assessments | Absolute change in Waist Circumference between baseline and 52 week assessments | 52 Weeks - Baseline |
| Change in Body Mass Index Between Baseline and 52 Week Assessments |
Inclusion Criteria:
An Adult Patient (At Least 18 Years Of Age) With A Clinical Identification Of The Metabolic Syndrome Using The IDF Definition:
and untreated hypertension with bp equal or greater than 140/90 mm Hg but bp < 180/110 mm Hg
or a patient receiving one or two antihypertensive agent(s) (diuretics, ace inhibitors, angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) and whose blood pressure is not controlled:
or a patient whose hypertension is controlled (< 140/90 mm hg) with a single anti-hypertensive agent (diuretics, ace inhibitors, and angiotensin II receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) but who is unsatisfied or experiencing side effects warranting a discontinuation of the previous treatment and at one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20147971 | Result | Racine N, Hamet P, Sampalis JS, Longo N, Bastien N. A 52-week prospective, cohort study of the effects of losartan with or without hydrochlorothiazide (HCTZ) in hypertensive patients with metabolic syndrome. J Hum Hypertens. 2010 Nov;24(11):739-48. doi: 10.1038/jhh.2010.3. Epub 2010 Feb 11. |
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24 patients not included in the Intention to Treat (ITT) analysis because they did not receive study medication and had no follow up visits. Total ITT population = 1714.
First Patient In: 12-Sep-2005 Last Patient In: 29-Dec-2006 Last Patient Last Visit: 31-Jan-08 Total number of Sites (General Practitioners and Family Physicians in Canada): 209
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan +/- Hydrochlorothiazide | Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.
| 52 Weeks - Baseline |
| Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments | Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments. | 52 Weeks - Baseline |
Absolute change in Body Mass Index Baseline and 52 week assessments
| 52 Weeks - Baseline |
| Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments | Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks - LDL-C Baseline) / (LDL-C Baseline)]. | 52 Weeks - Baseline |
| Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments | Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks - HDL-C 52 Baseline) / (HDL-C Baseline)]. | 52 Weeks - Baseline |
| Percent Change in Triglycerides Between Baseline and 52 Week Assessments | Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks - Triglycerides Baseline) / (Triglycerides Baseline)]. | 52 Weeks - Baseline |
| Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments | Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks - Total Cholesterol Baseline) / (Total Cholesterol Baseline)]. | 52 Weeks - Baseline |
| Absolute Change in Uric Acid Between Baseline and 52 Week Assessments | Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks - Uric Acid Baseline. | 52 Weeks - Baseline |
| Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments | Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks - C Reactive Protein Baseline. | 52 Weeks - Baseline |
| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 32 |
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| Week 52 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan +/- Hydrochlorothiazide | Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg. |
| 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, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | Kg/m2 |
| ||||||||||||||||||||||
| C-Reactive Protein | Mean | Standard Deviation | mg/L |
| ||||||||||||||||||||||
| Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Fasting Blood Glucose | Mean | Standard Deviation | mmol/L |
| ||||||||||||||||||||||
| Heart Rate | Mean | Standard Deviation | Beats per Minute (BPM) |
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| Hemoglobin A1c | Mean | Standard Deviation | Percent |
| ||||||||||||||||||||||
| High Density Lipoprotein-C | Mean | Standard Deviation | mol/L |
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| Low Density Lipoprotein-C | Mean | Standard Deviation | mmol/L |
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| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
| ||||||||||||||||||||||
| Total Cholesterol | Mean | Standard Deviation | mmol/L |
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| Triglycerides | Mean | Standard Deviation | mmol/L |
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| Uric Acid | Mean | Standard Deviation | mmol/L |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | Kilograms (Kg) |
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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 Hemoglobin A1c Between 52 Weeks and Baseline | Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value. | Per Protocol | Posted | Median | Standard Deviation | Percent | 52 Weeks - Baseline |
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| Primary | Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments | Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments. | Per Protocol | Posted | Mean | Standard Deviation | mmol/L | 52 Weeks - Baseline |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Target Blood Pressure | Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks | ITT and Per Protocol | Posted | Number | Participants | 52 Weeks |
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| Secondary | Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments | Absolute change in Systolic Blood Pressure between baseline and 52 week assessments. | Per Protocol | Posted | Mean | Standard Deviation | mm Hg | 52 Weeks - Baseline |
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| Secondary | Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments | Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments. | Per Protocol | Posted | Mean | Standard Deviation | mm Hg | 52 Weeks - Baseline |
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| Other Pre-specified | Change in Waist Circumference Between Baseline and 52 Week Assessments | Absolute change in Waist Circumference between baseline and 52 week assessments | Per Protocol | Posted | Mean | Standard Deviation | cm | 52 Weeks - Baseline |
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| Other Pre-specified | Change in Body Mass Index Between Baseline and 52 Week Assessments | Absolute change in Body Mass Index Baseline and 52 week assessments | Per Protocol | Posted | Mean | Standard Deviation | Kg/m2 | 52 Weeks - Baseline |
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| Other Pre-specified | Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments | Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks - LDL-C Baseline) / (LDL-C Baseline)]. | Per Protocol | Posted | Mean | Standard Deviation | Percent Change | 52 Weeks - Baseline |
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| Other Pre-specified | Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments | Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks - HDL-C 52 Baseline) / (HDL-C Baseline)]. | Per Protocol | Posted | Mean | Standard Deviation | Percent Change | 52 Weeks - Baseline |
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| Other Pre-specified | Percent Change in Triglycerides Between Baseline and 52 Week Assessments | Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks - Triglycerides Baseline) / (Triglycerides Baseline)]. | Per Protocol | Posted | Median | Standard Deviation | Percent Change | 52 Weeks - Baseline |
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| Other Pre-specified | Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments | Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks - Total Cholesterol Baseline) / (Total Cholesterol Baseline)]. | Per Protocol | Posted | Mean | Standard Deviation | Percent Change | 52 Weeks - Baseline |
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| Other Pre-specified | Absolute Change in Uric Acid Between Baseline and 52 Week Assessments | Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks - Uric Acid Baseline. | Per Protocol | Posted | Mean | Standard Deviation | mmol/L | 52 Weeks - Baseline |
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| Other Pre-specified | Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments | Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks - C Reactive Protein Baseline. | Per Protocol | Posted | Mean | Standard Deviation | mg/L | 52 Weeks - Baseline |
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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 | Overall ITT | 35 | 1,714 | 198 | 1,714 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Acute depression | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
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| Acute renal insufficiency | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
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| Anaphylaxis | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Atherosclerotic cardiovascular disease | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 10. | Systematic Assessment |
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| Bronchitis asthmatic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Cardiac catheterization | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Cerebral vascular accident | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 10.1 | Systematic Assessment |
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| Gastric Ulcer | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Hip Replacement | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
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| Ileostomy | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
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| Infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Lymphoma grade IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Multiple sclerosis aggravated | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Numbness of Upper Arm | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Rotator Cuff Repair | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
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| Single Vessel Disease | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Subarachnoid Hemorrhage | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Superficial Femoral Arterial Stenosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
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| Ulcer Bleeding Gastric | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Blood Glucose Increased (per investigator's clinical judgment) | Investigations | MedDRA 10.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C505809 | hydrochlorothiazide, losartan drug combination |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
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| 52.01 - 58.00 |
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| 58.01 - 65.00 |
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| >=65.00 |
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| Missing |
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| Asian |
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| Native American |
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| Other |
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| Missing |
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