Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia

LG Life Sciences

Status and phase: Completed; Phase 3

Conditions: Hypertension,; Hyperlipidemia

Treatments: Drug: Valsartan 160mg; Drug: Rosuvastatin 20mg placebo; Drug: Valsartan 160mg placebo; Drug: Rosuvastatin 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01918332

LG-VRCL002

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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168 participants in 4 patient groups, including a placebo group

Valsartan 160mg, Rosuvastatin 20mg

Experimental group

Description:

Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.

Treatment:

Drug: Rosuvastatin 20mg

Drug: Valsartan 160mg

Valsartan 160mg, Rosuvastatin 20mg placebo

Active Comparator group

Description:

Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

Treatment:

Drug: Rosuvastatin 20mg placebo

Drug: Valsartan 160mg

Valsartan 160mg placebo, Rosuvastatin 20mg

Active Comparator group

Description:

Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.

Treatment:

Drug: Rosuvastatin 20mg

Drug: Valsartan 160mg placebo

Placebo

Placebo Comparator group

Description:

Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

Treatment:

Drug: Rosuvastatin 20mg placebo

Drug: Valsartan 160mg placebo