Hypertension,, Hyperlipidemia
Conditions
Brief summary
This study aims to evaluate the efficacy and safety of the coadministration of valsartan (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered alone in patients with hypertension and hyperlipidemia.
Interventions
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patient aged 20-80 years who has hypertension and hyperlipidemia 2. Patient who has a Hypertension 3. Patient who has a Hyperlipidemia according to NCEP-ATP III guideline(2004) 4. Patient who signed the Informed Consent Form after receiving an explanation on the purpose, methods, and effect of the study
Exclusion criteria
1. If blood pressure and fasting serum lipid level measured at screening and Visit 2 (0 week) satisfy the following criteria 1) sitSBP≥180mmHg or sitDBP≥110mmHg (For high risk group, sitSBP≥ 160mmHg or sitDBP ≥100mmHg ) 2) LDL-C\>250mg/dL , or TG≥ 400mg/dL 2. If sitSBP difference between the right and left arms \>20mmHg or sitDBP difference between the right and left arms \> 10mmHg at screening 3. When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg 4. Patient with orthostatic hypotension accompanying symptoms at screening (decrease in sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sitDBP Changes at Week 8 From Baseline | 8 weeks | sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline |
| LDL-C Percentage Changes at Week 8 From Baseline | 8 weeks | LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Valsartan 160mg, Rosuvastatin 20mg Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg | 41 |
| Valsartan 160mg, Rosuvastatin 20mg Placebo Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg
Rosuvastatin 20mg placebo | 40 |
| Valsartan 160mg Placebo, Rosuvastatin 20mg Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Rosuvastatin 20mg
Valsartan 160mg placebo | 35 |
| Placebo Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Valsartan 160mg placebo
Rosuvastatin 20mg placebo | 44 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | lipid result by central lab did not meet | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 6 | 2 | 6 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 2 | 3 |
Baseline characteristics
| Characteristic | Valsartan 160mg, Rosuvastatin 20mg | Valsartan 160mg, Rosuvastatin 20mg Placebo | Valsartan 160mg Placebo, Rosuvastatin 20mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 16 Participants | 14 Participants | 15 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 24 Participants | 21 Participants | 29 Participants | 100 Participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 7 Participants | 10 Participants | 47 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 28 Participants | 34 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 43 | 7 / 41 | 4 / 37 | 5 / 45 |
| serious Total, serious adverse events | 1 / 43 | 0 / 41 | 0 / 37 | 0 / 45 |
Outcome results
Primary
LDL-C Percentage Changes at Week 8 From Baseline
LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline
Time frame: 8 weeks
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| V160+R20 & V160 | LDL-C Percentage Changes at Week 8 From Baseline | -49.91 percent change |
| R20 & Placebo | LDL-C Percentage Changes at Week 8 From Baseline | -2.38 percent change |
Primary
sitDBP Changes at Week 8 From Baseline
sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline
Time frame: 8 weeks
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| V160+R20 & V160 | sitDBP Changes at Week 8 From Baseline | -9.24 mmHg |
| R20 & Placebo | sitDBP Changes at Week 8 From Baseline | -2.9 mmHg |