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| ID | Type | Description | Link |
|---|---|---|---|
| MK0954-315 | |||
| 2006_002 |
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This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Losartan |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: losartan +/- HCTZ | Drug | Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment is approximately 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 | Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 | Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 | Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. |
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Inclusion Criteria:
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 |
|---|---|---|---|
| 18328120 | Background | Oparil S, Abate N, Chen E, Creager MA, Galet V, Jia G, Julius S, Lerman A, Lyle PA, Pool J, Tershakovec AM. A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. Curr Med Res Opin. 2008 Apr;24(4):1101-14. doi: 10.1185/030079908x280716. Epub 2008 Mar 6. |
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Prior antihypertensive medications were withdrawn/ tapered before patients entered the 4-week placebo run-in period.
Patients were recruited at 51 sites in the United States.
Prime Therapy Period: April 2006 to February 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan | Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg |
| FG001 | Placebo | Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan | Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg |
| BG001 | Placebo |
| 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 | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 | Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment. | Posted | Least Squares Mean | Standard Error | mm Hg | At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
|
Week 0 through Week 16.
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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 | Losartan | Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 9.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA Version 9.1 | Non-systematic Assessment |
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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 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Comparator: Placebo | Drug | Placebo to losartan once daily for 4 weeks in run-in period. Then, placebo to losartan or losartan/HCTZ once daily for approximately 16 weeks. |
|
| At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16 | Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16 | Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
| Lost to Follow-up |
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| Protocol Violation |
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| Withdrawal by Subject |
|
| Other |
|
Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Sitting Diastolic Blood Pressure (SiDBP) | Mean | Standard Deviation | mm Hg |
|
| Sitting Systolic Blood Pressure (SiSBP) | Mean | Standard Deviation | mm Hg |
|
| OG001 | Placebo | Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg |
|
|
| Primary | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 | Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment. | Posted | Least Squares Mean | Standard Error | mm Hg | At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
|
|
|
| Primary | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment. | Posted | Least Squares Mean | Standard Error | mm Hg | At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
|
|
|
| Primary | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 | Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment. | Posted | Least Squares Mean | Standard Error | mm Hg | At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
|
|
|
| Primary | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16 | Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment. | Posted | Least Squares Mean | Standard Error | mm Hg | At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
|
|
|
| Primary | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16 | Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16. A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline. | An "all patients treated" approach was employed, patients included had at least 1 dose post baseline and 1 measurement at baseline and during treatment. | Posted | Least Squares Mean | Standard Error | mm Hg | At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM) |
|
|
|
| 1 |
| 127 |
| 4 |
| 127 |
| EG001 | Placebo | Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg | 1 | 134 | 7 | 134 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 9.1 | Non-systematic Assessment |
|
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.