Stage II Hypertension
Conditions
Keywords
Candesartan Cilexetil, hydrochlorothiazide, severe hypertension
Brief summary
To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
Interventions
DRUGCandesartan Cilexetil
Candesartan Cilexetil 16 mg oral
DRUGHydrochlorothiazide
Hydrochlorothiazide 12.5 mg
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs
Exclusion criteria
* Current serum-creatinine \>3 mg/dL, Current serum-potassium \>5.5 mmol/L, 16. * Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy | 4 weeks | Mean of the changed DBP from baseline after 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy | 4 weeks | Percent of the patients achieving goal DBP and SBP after 4 weeks |
| Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy | 8 weeks | Percent of patients achieving goal of DBP |
| Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy | 8 weeks | Changed SBP from baseline after 8 weeks |
| Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy | 4 weeks | Mean of the changed SBP from baseline after 4 weeks |
| Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks) | 8 weeks | Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks |
| Compliance Levels at 4 Weeks and 8 Weeks of Therapy | 8 weeks | Percent of the number of returened pills to the number of prescrited pills |
| Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy | 8 weeks | Change of hs-CRP from basline after 8 weeks |
Countries
South Korea
Participant flow
Recruitment details
253 enrolled, 20 screening failure, 223 randomised, 198 completed
Participants by arm
| Arm | Count |
|---|---|
| Candesartan Cilexetil/Hydroclorozide Combination Therapy candesartan cilexetil/Hydroclorozide combination therapy | 117 |
| Candesartan Cilexetil Monotherapy candesartan cilexetil monotherapy | 116 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Safety Reason | 8 | 7 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Candesartan Cilexetil/Hydroclorozide Combination Therapy | Candesartan Cilexetil Monotherapy | Total |
|---|---|---|---|
| Age Continuous | 51.00 years STANDARD_DEVIATION 10 | 47.80 years STANDARD_DEVIATION 10 | 48.90 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 42 Participants | 38 Participants | 80 Participants |
| Sex: Female, Male Male | 75 Participants | 78 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / — | 3 / — |
| serious Total, serious adverse events | 1 / — | 2 / — |
Outcome results
Primary
Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy
Mean of the changed DBP from baseline after 4 weeks
Time frame: 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Candesartan Cilexetil/Hydroclorozide Combination Therapy | Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy | -17.0 mmHg | Standard Deviation 0.89 |
| Candesartan Cilexetil Monotherapy | Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy | -14.1 mmHg | Standard Deviation 0.88 |
Secondary
Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy
Change of hs-CRP from basline after 8 weeks
Time frame: 8 weeks
Secondary
Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy
Mean of the changed SBP from baseline after 4 weeks
Time frame: 4 weeks
Secondary
Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy
Changed SBP from baseline after 8 weeks
Time frame: 8 weeks
Secondary
Compliance Levels at 4 Weeks and 8 Weeks of Therapy
Percent of the number of returened pills to the number of prescrited pills
Time frame: 8 weeks
Secondary
Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks)
Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks
Time frame: 8 weeks
Secondary
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy
Percent of the patients achieving goal DBP and SBP after 4 weeks
Time frame: 4 weeks
Secondary
Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy
Percent of patients achieving goal of DBP
Time frame: 8 weeks