Hypertension
Conditions
Brief summary
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.
Interventions
DRUGlosartan potassium
losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
DRUGComparator: placebo
placebo to losartan tablet q.a.m. , for 12 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has been diagnosed with mild to moderate hypertension * Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure
Exclusion criteria
* Pregnant of lactating female patients * Secondary hypertension or history of malignant hypertension * Sitting systolic blood pressure \> 210 mmHg * History of stroke * History of myocardial infarction with in the past year * Current of prior history of heart failure * Known hypersensitivity to losartan * Obesity * Patients known to be HIV positive or known to be positive for Hepatitis B * Absence of one kidney * Patient is abusing or previously abused alcohol or drugs with in past two years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) | 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 |
| Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | At baseline and at 12 weeks (6 hours after last morning dose) | Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12 |
| Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Died | 12 weeks | Patients who died during the 12-week treatment period |
| Number of Patients With Laboratory Adverse Experiences (LAEs) | 12 weeks | 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 |
| Number of Patients With Clinical Adverse Experiences (CAEs) | 12 weeks | 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 |
| Number of Patients With Drug-related LAEs | 12 weeks | Patients with drug-related LAEs during the 12-week treatment period |
| Number of Patients Discontinued Due to LAEs | 12 weeks | Patients discontinued due to LAEs during the 12-week treatment period |
| Number of Patients With Serious LAEs | 12 weeks | 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 |
| Number of Patients With Serious CAEs | 12 weeks | 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 |
| Number of Patients With Drug-related CAEs | 12 weeks | 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 |
| Number of Patients Discontinued Due to CAEs | 12 weeks | Patients discontinued due to CAEs during the 12-week treatment period |
Participant flow
Recruitment details
Patients were recruited at 37 sites in the United States. Prime Therapy Period: May, 1992 to January1993
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Losartan placebo orally once daily for 12 weeks | 108 |
| Losartan 25 mg q.d. Losartan 25 mg orally once daily (q.d.) for 12 weeks | 108 |
| Losartan 50 mg q.d. Losartan 50 mg orally once daily (q.d.) for 12 weeks | 106 |
| Losartan 25 mg (b.i.d.) Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks | 106 |
| Total | 428 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 0 | 3 | 3 |
| Overall Study | Lack of Efficacy | 9 | 2 | 5 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 | 0 |
| Overall Study | Protocol Violation | 3 | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 1 | 3 |
Baseline characteristics
| Characteristic | Placebo | Losartan 25 mg q.d. | Losartan 50 mg q.d. | Losartan 25 mg (b.i.d.) | Total |
|---|---|---|---|---|---|
| Age Continuous | 54.6 years STANDARD_DEVIATION 10.6 | 53.0 years STANDARD_DEVIATION 10.7 | 54.0 years STANDARD_DEVIATION 10.1 | 52.4 years STANDARD_DEVIATION 10.1 | 53.5 years STANDARD_DEVIATION 10.4 |
| Race/Ethnicity, Customized Black | 21 participants | 22 participants | 17 participants | 10 participants | 70 participants |
| Race/Ethnicity, Customized Caucasian | 84 participants | 79 participants | 82 participants | 89 participants | 334 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 4 participants | 5 participants | 4 participants | 15 participants |
| Race/Ethnicity, Customized Latin American | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Oriental | 1 participants | 2 participants | 2 participants | 2 participants | 7 participants |
| Race/Ethnicity, Customized Vietnamese | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 38 Participants | 41 Participants | 36 Participants | 36 Participants | 151 Participants |
| Sex: Female, Male Male | 70 Participants | 67 Participants | 70 Participants | 70 Participants | 277 Participants |
| Sitting Diastolic Blood Pressure (SiDBP) | 101.5 mm Hg STANDARD_DEVIATION 5.1 | 101.8 mm Hg STANDARD_DEVIATION 5.5 | 102.4 mm Hg STANDARD_DEVIATION 6.4 | 102.0 mm Hg STANDARD_DEVIATION 5.3 | 101.9 mm Hg STANDARD_DEVIATION 5.6 |
Outcome results
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
Time frame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | -2.0 mm Hg | Standard Deviation 8.4 |
| Losartan 25 mg q.d. | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | -5.8 mm Hg | Standard Deviation 6.7 |
| Losartan 50 mg q.d. | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | -6.3 mm Hg | Standard Deviation 7.4 |
| Losartan 25 mg (b.i.d.) | Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | -8.0 mm Hg | Standard Deviation 7.9 |
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.
Time frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category I | 12 Participants |
| Placebo | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category III | 80 Participants |
| Placebo | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category II | 10 Participants |
| Losartan 25 mg q.d. | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category I | 23 Participants |
| Losartan 25 mg q.d. | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category III | 68 Participants |
| Losartan 25 mg q.d. | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category II | 14 Participants |
| Losartan 50 mg q.d. | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category II | 14 Participants |
| Losartan 50 mg q.d. | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category I | 26 Participants |
| Losartan 50 mg q.d. | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category III | 61 Participants |
| Losartan 25 mg (b.i.d.) | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category I | 33 Participants |
| Losartan 25 mg (b.i.d.) | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category III | 53 Participants |
| Losartan 25 mg (b.i.d.) | Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | Category II | 15 Participants |
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
Time frame: At baseline and at 12 weeks (6 hours after last morning dose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | -3.0 mm Hg | Standard Deviation 9.7 |
| Losartan 25 mg q.d. | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | -7.7 mm Hg | Standard Deviation 8.5 |
| Losartan 50 mg q.d. | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | -8.7 mm Hg | Standard Deviation 8.1 |
| Losartan 25 mg (b.i.d.) | Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 | -9.9 mm Hg | Standard Deviation 9.5 |
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
Time frame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | -0.2 mm Hg | Standard Deviation 15.1 |
| Losartan 25 mg q.d. | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | -7.2 mm Hg | Standard Deviation 13.9 |
| Losartan 50 mg q.d. | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | -7.6 mm Hg | Standard Deviation 12.6 |
| Losartan 25 mg (b.i.d.) | Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 | -8.8 mm Hg | Standard Deviation 13 |
Other Pre-specified
Number of Patients Discontinued Due to CAEs
Patients discontinued due to CAEs during the 12-week treatment period
Time frame: 12 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Discontinued Due to CAEs | Discontinued due to CAEs | 10 Participants |
| Placebo | Number of Patients Discontinued Due to CAEs | Not discontinued due to CAEs | 98 Participants |
| Losartan 25 mg q.d. | Number of Patients Discontinued Due to CAEs | Not discontinued due to CAEs | 108 Participants |
| Losartan 25 mg q.d. | Number of Patients Discontinued Due to CAEs | Discontinued due to CAEs | 0 Participants |
| Losartan 50 mg q.d. | Number of Patients Discontinued Due to CAEs | Discontinued due to CAEs | 1 Participants |
| Losartan 50 mg q.d. | Number of Patients Discontinued Due to CAEs | Not discontinued due to CAEs | 105 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients Discontinued Due to CAEs | Discontinued due to CAEs | 3 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients Discontinued Due to CAEs | Not discontinued due to CAEs | 103 Participants |
Other Pre-specified
Number of Patients Discontinued Due to LAEs
Patients discontinued due to LAEs during the 12-week treatment period
Time frame: 12 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Discontinued Due to LAEs | Discontinued due to LAEs | 0 Participants |
| Placebo | Number of Patients Discontinued Due to LAEs | Not discontinued due to LAEs | 104 Participants |
| Losartan 25 mg q.d. | Number of Patients Discontinued Due to LAEs | Not discontinued due to LAEs | 105 Participants |
| Losartan 25 mg q.d. | Number of Patients Discontinued Due to LAEs | Discontinued due to LAEs | 0 Participants |
| Losartan 50 mg q.d. | Number of Patients Discontinued Due to LAEs | Discontinued due to LAEs | 2 Participants |
| Losartan 50 mg q.d. | Number of Patients Discontinued Due to LAEs | Not discontinued due to LAEs | 101 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients Discontinued Due to LAEs | Discontinued due to LAEs | 0 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients Discontinued Due to LAEs | Not discontinued due to LAEs | 104 Participants |
Other Pre-specified
Number of Patients Who Died
Patients who died during the 12-week treatment period
Time frame: 12 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Died | Who Died | 2 Participants |
| Placebo | Number of Patients Who Died | Alive | 106 Participants |
| Losartan 25 mg q.d. | Number of Patients Who Died | Alive | 108 Participants |
| Losartan 25 mg q.d. | Number of Patients Who Died | Who Died | 0 Participants |
| Losartan 50 mg q.d. | Number of Patients Who Died | Who Died | 0 Participants |
| Losartan 50 mg q.d. | Number of Patients Who Died | Alive | 106 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients Who Died | Who Died | 1 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients Who Died | Alive | 105 Participants |
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
Time frame: 12 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 63 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 45 Participants |
| Losartan 25 mg q.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 49 Participants |
| Losartan 25 mg q.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 59 Participants |
| Losartan 50 mg q.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 59 Participants |
| Losartan 50 mg q.d. | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 47 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 60 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 46 Participants |
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
Time frame: 12 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Drug-related CAEs | With drug-related CAEs | 20 Participants |
| Placebo | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 88 Participants |
| Losartan 25 mg q.d. | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 96 Participants |
| Losartan 25 mg q.d. | Number of Patients With Drug-related CAEs | With drug-related CAEs | 12 Participants |
| Losartan 50 mg q.d. | Number of Patients With Drug-related CAEs | With drug-related CAEs | 21 Participants |
| Losartan 50 mg q.d. | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 85 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Drug-related CAEs | With drug-related CAEs | 16 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Drug-related CAEs | Without drug-related CAEs | 90 Participants |
Other Pre-specified
Number of Patients With Drug-related LAEs
Patients with drug-related LAEs during the 12-week treatment period
Time frame: 12 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Drug-related LAEs | With drug-related LAEs | 4 Participants |
| Placebo | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 100 Participants |
| Losartan 25 mg q.d. | Number of Patients With Drug-related LAEs | With drug-related LAEs | 5 Participants |
| Losartan 25 mg q.d. | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 100 Participants |
| Losartan 50 mg q.d. | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 99 Participants |
| Losartan 50 mg q.d. | Number of Patients With Drug-related LAEs | With drug-related LAEs | 4 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Drug-related LAEs | Without drug-related LAEs | 104 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Drug-related LAEs | With drug-related LAEs | 0 Participants |
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
Time frame: 12 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 7 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 97 Participants |
| Losartan 25 mg q.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 98 Participants |
| Losartan 25 mg q.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 7 Participants |
| Losartan 50 mg q.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 7 Participants |
| Losartan 50 mg q.d. | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 96 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 4 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 100 Participants |
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
Time frame: 12 weeks
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Serious CAEs | Without Serious CAEs | 104 Participants |
| Placebo | Number of Patients With Serious CAEs | With Serious CAEs | 4 Participants |
| Losartan 25 mg q.d. | Number of Patients With Serious CAEs | With Serious CAEs | 1 Participants |
| Losartan 25 mg q.d. | Number of Patients With Serious CAEs | Without Serious CAEs | 107 Participants |
| Losartan 50 mg q.d. | Number of Patients With Serious CAEs | With Serious CAEs | 1 Participants |
| Losartan 50 mg q.d. | Number of Patients With Serious CAEs | Without Serious CAEs | 105 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Serious CAEs | Without Serious CAEs | 103 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Serious CAEs | With Serious CAEs | 3 Participants |
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
Time frame: 12 weeks
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Serious LAEs | With serious LAEs | 0 Participants |
| Placebo | Number of Patients With Serious LAEs | Without serious LAEs | 104 Participants |
| Losartan 25 mg q.d. | Number of Patients With Serious LAEs | Without serious LAEs | 105 Participants |
| Losartan 25 mg q.d. | Number of Patients With Serious LAEs | With serious LAEs | 0 Participants |
| Losartan 50 mg q.d. | Number of Patients With Serious LAEs | With serious LAEs | 0 Participants |
| Losartan 50 mg q.d. | Number of Patients With Serious LAEs | Without serious LAEs | 103 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Serious LAEs | With serious LAEs | 0 Participants |
| Losartan 25 mg (b.i.d.) | Number of Patients With Serious LAEs | Without serious LAEs | 104 Participants |