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This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan/amlodipine Treatment Arm | Experimental | One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks. |
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| Amlodipine Treatment Arm | Active Comparator | 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan (+) amlodipine | Drug | One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 | Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4 | Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. | Baseline and Week 4 |
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Inclusion criteria
Participants with essential hypertension:
Randomization (Visit 3)
After dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:
Exclusion criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan/Amlodipine | One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks. |
| FG001 | Amlodipine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo to match losartan/amlodipine tablets | Drug | One tablet containing placebo, orally, once daily, for 8 weeks. |
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| Amlodipine camsylate | Drug | 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. |
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| Placebo to match amlodipine | Drug | 2 tablets containing placebo, orally, once daily, for 8 weeks. |
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| Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 | Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. | Baseline and Week 8 |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 | Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. | Baseline and Week 4 |
| Percentage of Participants Who Achieve Target Blood Pressure at Week 8 | Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline. | Week 8 |
| Percentage of Participants Who Achieve Target Blood Pressure at Week 4 | Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline. | Week 4 |
| Percentage of Participants Who Had Peripheral Edema During the Study | A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema. | up to 8 weeks |
| Change From Baseline in Ankle Circumference at Week 8 | Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error. | Baseline and Week 8 |
2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan/Amlodipine | One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks. |
| BG001 | Amlodipine | 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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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 | Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 | Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 8 |
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| Secondary | Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4 | Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 4 |
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| Secondary | Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 | Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 8 |
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| Secondary | Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 | Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded. | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 4 |
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| Secondary | Percentage of Participants Who Achieve Target Blood Pressure at Week 8 | Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline. | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | Posted | Number | Percentage of Participants | Week 8 |
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| Secondary | Percentage of Participants Who Achieve Target Blood Pressure at Week 4 | Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline. | Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement. | Posted | Number | Percentage of Participants | Week 4 |
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| Secondary | Percentage of Participants Who Had Peripheral Edema During the Study | A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema. | Safety Set defined as all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | up to 8 weeks |
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| Secondary | Change From Baseline in Ankle Circumference at Week 8 | Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error. | All participants who received at least 1 dose of study drug and had available data for ankle circumference. | Posted | Mean | Standard Deviation | mm | Baseline and Week 8 |
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10 weeks
Safety Set defined as all participants who received at least 1 dose of study drug.
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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 100mg/Amlodipine 5mg | One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks | 6 | 168 | 6 | 168 | ||
| EG001 | Amlodipine 10mg | 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks. | 5 | 166 | 11 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| ANGINA UNSTABLE | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 16.0 | Systematic Assessment |
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| ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| EXCORIATION | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| PROTEINURIA | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| UTERINE HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
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| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| HEADACHE | Nervous system disorders | MedDRA 16.0 | 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 |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000710253 | amlodipine-losartan drug combination |
| D017311 | Amlodipine |
| ID | Term |
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| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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