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

Hyperlipidemia Clinical Trial

Official title:

A Multicenter, Randomized, Factorial, Double-blinded, Double-dummy Phase Ⅲ Trial to Evaluate the Efficacy and Safety of the Coadministration of Valsartan 160mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone in Patients With Hypertension and Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918332
• Other study ID #: LG-VRCL002
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2013
• Last updated: December 8, 2014
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Hypertension,

Intervention

Drug:
• Valsartan 160mg

• Rosuvastatin 20mg

• Valsartan 160mg placebo

• Rosuvastatin 20mg placebo

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sitDBP Changes at Week 8 From Baseline	sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline	8 weeks	No
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	8 weeks	No