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

Last updated: December 8, 2014
Sponsor: LG Life Sciences
Overall Status: Completed

Phase

3

Condition

Circulation Disorders

Williams Syndrome

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT01918332
LG-VRCL002
  • Ages 20-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thepurpose, methods, and effect of the study

Exclusion

Exclusion Criteria:

  1. If blood pressure and fasting serum lipid level measured at screening and Visit 2 (0week) satisfy the following criteria 1) sitSBP≥180mmHg or sitDBP≥110mmHg (For highrisk 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 differencebetween the right and left arms > 10mmHg at screening

  3. When blood pressure is repeatedly measured from the selected arm at screening, ifsitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg

  4. Patient with orthostatic hypotension accompanying symptoms at screening (decrease insitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )

Study Design

Total Participants: 168
Study Start date:
April 01, 2012
Estimated Completion Date:
March 31, 2013

Connect with a study center

  • Yonsei University Health System Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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