Essential Hypertension
Conditions
Brief summary
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.
Interventions
DRUGolmesartan medoxomil
olmesartan medoxomil oral tablets, once daily for up to 12 weeks
DRUGlosartan potassium
losartan oral tablets, once daily for up to 12 weeks
Sponsors
Daiichi Sankyo Taiwan Ltd.
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diastolic BP 95 mm Hg - 114 mm Hg inclusive * No participation in any clinical trial for the last 3 months
Exclusion criteria
* Secondary hypertension * Malignant hypertension * Severe arterial hypertension * Significant cardiovascular disease * History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder * Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Sitting dBP From Baseline to Week 12 | Baseline to 12 weeks | The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12. |
Countries
Taiwan
Participant flow
Recruitment details
A total of 181 subjects were screened at 3 study sites in Taiwan from May 2002 to April 2003, and 51 subjects had dropped as screen failure.
Pre-assignment details
After a taper off period for 1 week, if necessary, and a placebo run-in period for 2 weeks, 130 subjects were randomized to olmesartan 20mg and losartan 50mg by 1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| Olmesartan Medoxomil olmesartan medoxomil oral tablets, once daily for up to 12 weeks | 65 |
| Losartan Potassium losartan potassium oral tablets, once daily for up to 12 weeks | 65 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Randomization criteria not met | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Losartan Potassium | Total | Olmesartan Medoxomil |
|---|---|---|---|
| Age Continuous | 48.34 years STANDARD_DEVIATION 9.17 | 48.98 years STANDARD_DEVIATION 9.94 | 49.63 years STANDARD_DEVIATION 10.69 |
| Race/Ethnicity, Customized Taiwanese | 65 participants | 130 participants | 65 participants |
| Region of Enrollment Taiwan | 65 participants | 130 participants | 65 participants |
| Sex: Female, Male Female | 23 Participants | 56 Participants | 33 Participants |
| Sex: Female, Male Male | 42 Participants | 74 Participants | 32 Participants |
Outcome results
Primary
Mean Change of Sitting dBP From Baseline to Week 12
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.
Time frame: Baseline to 12 weeks
Population: Four randomized subjects (3 in olmesartan, 1 in losartan) were excluded from the analysis due to a lack of post-treatment efficacy evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olmesartan Medoxomil | Mean Change of Sitting dBP From Baseline to Week 12 | -14.80 mmHg | Standard Error 12.5 |
| Losartan Potassium | Mean Change of Sitting dBP From Baseline to Week 12 | -11.60 mmHg | Standard Error 9.46 |