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| ID | Type | Description | Link |
|---|---|---|---|
| MK0954-065 |
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The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of Losartan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | Losartan 50 q.a.m. |
|
| 3 | Experimental | Losartan 25 b.i.d. |
|
| 4 | Experimental | Losartan 25 q.a.m. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| losartan potassium | Drug | losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinical Adverse Experiences (CAEs) | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Patients could be randomized if sitting diastolic blood pressure (SiDBP) after 2 and 4 weeks of placebo washout was 95-115 mm Hg and the difference between measurements at the 2 visits did not differ by >7 mm Hg.
Patients were recruited at 37 sites in the United States. Prime Therapy Period: May, 1992 to January1993
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Losartan placebo orally once daily for 12 weeks |
| FG001 | Losartan 25 mg q.d. | Losartan 25 mg orally once daily (q.d.) for 12 weeks |
| FG002 | Losartan 50 mg q.d. | Losartan 50 mg orally once daily (q.d.) for 12 weeks |
| FG003 | Losartan 25 mg (b.i.d.) | Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Losartan placebo orally once daily for 12 weeks |
| BG001 | Losartan 25 mg q.d. | Losartan 25 mg orally once daily (q.d.) for 12 weeks |
| 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 Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12 | The primary analysis employed an "all patients treated" approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | Posted | Mean | Standard Deviation | mm Hg | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) |
|
Note that deaths are not entered under "drop reasons" in the participant flow panel because the patients who died are already counted as dropped due to adverse event.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck & Co., Inc. | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Comparator: placebo | Drug | placebo to losartan tablet q.a.m. , for 12 weeks |
|
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 |
Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12 |
| At baseline and at 12 weeks (6 hours after last morning dose) |
| Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg or increased were in Category III. | 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks |
| Number of Patients With Serious CAEs |
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| 12 weeks |
| Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period | 12 weeks |
| Number of Patients Discontinued Due to CAEs | Patients discontinued due to CAEs during the 12-week treatment period | 12 weeks |
| Number of Patients Who Died | Patients who died during the 12-week treatment period | 12 weeks |
| Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | 12 weeks |
| Number of Patients With Serious LAEs | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | 12 weeks |
| Number of Patients With Drug-related LAEs | Patients with drug-related LAEs during the 12-week treatment period | 12 weeks |
| Number of Patients Discontinued Due to LAEs | Patients discontinued due to LAEs during the 12-week treatment period | 12 weeks |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Losartan 50 mg q.d. | Losartan 50 mg orally once daily (q.d.) for 12 weeks |
| BG003 | Losartan 25 mg (b.i.d.) | Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks |
| BG004 | 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 |
|
| Losartan 25 mg q.d. |
Losartan 25 mg orally once daily (q.d.) for 12 weeks |
| OG002 | Losartan 50 mg q.d. | Losartan 50 mg orally once daily (q.d.) for 12 weeks |
| OG003 | Losartan 25 mg (b.i.d.) | Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks |
|
|
| Secondary | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12 | An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | Posted | Mean | Standard Deviation | mm Hg | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) |
|
|
|
| Secondary | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12 | An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | Posted | Mean | Standard Deviation | mm Hg | At baseline and at 12 weeks (6 hours after last morning dose) |
|
|
|
| Secondary | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg or increased were in Category III. | An "all patients treated" approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available. | Posted | Number | Participants | 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients With Clinical Adverse Experiences (CAEs) | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients With Serious CAEs | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients With Drug-related CAEs | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients Discontinued Due to CAEs | Patients discontinued due to CAEs during the 12-week treatment period | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients Who Died | Patients who died during the 12-week treatment period | All patients who took study medication were included in the analysis. | Posted | Number | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients With Laboratory Adverse Experiences (LAEs) | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients With Serious LAEs | Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients With Drug-related LAEs | Patients with drug-related LAEs during the 12-week treatment period | All patients who took study medication and had any laboratory tests performed were included in the analysis. | Posted | Number | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Number of Patients Discontinued Due to LAEs | Patients discontinued due to LAEs during the 12-week treatment period | All patients who took study medication and had any laboratory tests performed were included in the analysis | Posted | Number | Participants | 12 weeks |
|
|
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| Category II |
|
| Category III |
|
| Without CAEs |
|
| Without Serious CAEs |
|
| Without drug-related CAEs |
|
| Not discontinued due to CAEs |
|
| Alive |
|
| Without LAEs |
|
| Without serious LAEs |
|
| Without drug-related LAEs |
|
| Not discontinued due to LAEs |
|