Hypertension
Conditions
Keywords
Essential hypertension, Combination therapy
Brief summary
The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone
Interventions
DRUGolmesartan medoxomil and a CCB
olmesartan medoxomil tablets and a CCB tablet once daily for 8 weeks
DRUGolmesartan medoxomil and a diuretic
olmesartan medoxomil tablets and a diuretic tablet, once daily for 8 weeks
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil * Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil
Exclusion criteria
* Patients with secondary hypertension * Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 | Baseline to week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) | At week 8 | Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence. |
| Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) | At week 8 | Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence. |
Countries
Japan
Participant flow
Recruitment details
A total of 172 patients were enrolled at 5 centers in Japan from February 12, 2005 to April 30, 2005.
Pre-assignment details
After the 4 to 6 weeks of olmesartan medoxomil monotherapy period, 105 patients who met the entry criteria for the combination therapy period were randomized to calcium channel blocker (of the dihydropyridine class) combination group or diuretic (of the thiazide class)combination group.
Participants by arm
| Arm | Count |
|---|---|
| Olmesartan Tablets and a Calcium Channel Blocker Tablet olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks | 53 |
| Olmesartan Medoxomil Tablets and a Diuretic olmesartan medoxomil tablets and a diuretic once daily for 8 weeks | 52 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Olmesartan Medoxomil Tablets and a Diuretic | Total | Olmesartan Tablets and a Calcium Channel Blocker Tablet |
|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 9.4 | 56.8 years STANDARD_DEVIATION 10.3 | 56.2 years STANDARD_DEVIATION 11.2 |
| Race/Ethnicity, Customized Japanese | 52 Participants | 105 Participants | 53 Participants |
| Region of Enrollment Japan | 52 participants | 105 participants | 53 participants |
| Sex: Female, Male Female | 20 Participants | 42 Participants | 22 Participants |
| Sex: Female, Male Male | 32 Participants | 63 Participants | 31 Participants |
Outcome results
Primary
The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
Time frame: Baseline to week 8
Population: Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olmesartan Tablets and a Calcium Channel Blocker Tablet | The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 | 34.0 Percent of participants |
| Olmesartan Medoxomil Tablets and a Diuretic | The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 | 59.2 Percent of participants |
p-value: 0.0158Fisher Exact
Secondary
Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.
Time frame: At week 8
Population: Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olmesartan Tablets and a Calcium Channel Blocker Tablet | Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) | 0 Percent of participants |
| Olmesartan Medoxomil Tablets and a Diuretic | Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings) | 7.7 Percent of participants |
p-value: 0.0566Fisher Exact
Secondary
Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.
Time frame: At week 8
Population: Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olmesartan Tablets and a Calcium Channel Blocker Tablet | Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) | 1.9 Percent of participants |
| Olmesartan Medoxomil Tablets and a Diuretic | Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values) | 44.2 Percent of participants |
p-value: <0.001Fisher Exact