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

Phase 3

Completed

• Conditions: Hyperlipidemia; Hypertension,
• Interventions: Drug: Valsartan 160mg; Drug: Valsartan 160mg placebo; Drug: Rosuvastatin 20mg placebo; Drug: Rosuvastatin 20mg

• Registration Number: NCT01918332
• Lead Sponsor: LG Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-08-05
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-07
• Results First Submitted: 2014-04-24
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-08
• Last Update Submitted: 2014-12-08
• Results First Posted: 2014-12-15
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yonsei University Health System Severance Hospital; 🇰🇷 Seoul, Korea, Republic of