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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_628 |
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This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| losartan /HCTZ combination tablet | Active Comparator | single dose losartan 100 mg/HCTZ 12.5 mg combination tablet |
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| losartan tablet + HCTZ capsule | Active Comparator | Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan potassium (+) hydrochlorothiazide (HCTZ) | Drug | Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC(0 to Infinity)) of Losartan | 0 to 36 Hours Post Dose | |
| Peak Plasma Concentration (Cmax) for Losartan | Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing. | 36 Hours Post Dose |
| Area Under the Curve (AUC(0 to Infinity)) of HCTZ | Plasma Area Under the Curve, a measure of drug exposure following dosing | 0 to 30 Hours Post Dose |
| Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ | Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing | 30 Hours Post Dose |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule |
| FG001 | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| losartan potassium | Drug | Single dose losartan 100 mg tablet in one of two treatment periods. |
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| hydrochlorothiazide (HCTZ) | Drug | Single dose HCTZ 12.5 mg capsule in one of two treatment periods. |
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Single dose losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All randomized patients |
| 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 | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Height | Mean | Full Range | Centimeters |
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| Weight | Mean | Full Range | kilograms |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Curve (AUC(0 to Infinity)) of Losartan | Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses. | Posted | Least Squares Mean | Standard Deviation | ng*hr/mL | 0 to 36 Hours Post Dose |
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| Primary | Peak Plasma Concentration (Cmax) for Losartan | Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing. | Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses. | Posted | Least Squares Mean | Standard Deviation | ng/mL | 36 Hours Post Dose |
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| Primary | Area Under the Curve (AUC(0 to Infinity)) of HCTZ | Plasma Area Under the Curve, a measure of drug exposure following dosing | Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses. | Posted | Least Squares Mean | Standard Deviation | ng*hr/mL | 0 to 30 Hours Post Dose |
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| Primary | Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ | Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing | Pharmacokinetic (PK) results were based on data from the 20 subjects who had blood drawn for the HCTZ assay. These 20 subjects were selected as the first 10 subjects from each treatment sequence who completed both periods of the study. | Posted | Least Squares Mean | Standard Deviation | ng/mL | 30 Hours Post Dose |
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Serious Adverse Events are reported by treatment group (Combination/Tablet+Capsule [N=38] or Tablet+Capsule/Combination [N=39]). For Other Adverse Events, the Combination/Tablet+Capsule group includes all subjects who received Combination Tablet (N=76) and the Tablet+Capsule/Combination group includes all subjects who received Tablet+Capsule (N=77)
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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-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule | 0 | 38 | 12 | 76 | ||
| EG001 | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet | 0 | 39 | 10 | 77 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 7.0 | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA 7.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 7.0 | Non-systematic Assessment |
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PK analyses included complete data from 75 subjects. 3 losartan/E-3174 concentrations from 3 different subjects were excluded from analyses due to gross deviations; 75 minutes-Treatment B, 75 minutes-Treatment A, & 15 minutes-Treatment A.
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 | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C505809 | hydrochlorothiazide, losartan drug combination |
| D019808 | Losartan |
| D006852 | Hydrochlorothiazide |
| 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 |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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