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OpenTrials
Completed

NCT Number: NCT01918332

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

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.

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Key information

Conditions

Hypertension, Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University Health System Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 20-80 years who has hypertension and hyperlipidemia
  • Patient who has a Hypertension
  • Patient who has a Hyperlipidemia according to NCEP-ATP III guideline(2004)
  • Patient who signed the Informed Consent Form after receiving an explanation on the purpose, methods, and effect of the study

Exclusion criteria

  • 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
  • If sitSBP difference between the right and left arms >20mmHg or sitDBP difference between the right and left arms > 10mmHg at screening
  • When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg
  • Patient with orthostatic hypotension accompanying symptoms at screening (decrease in sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )

Treatment and study plan

Valsartan 160mg

Drug

Other names: Diovan

Rosuvastatin 20mg

Drug

Other names: Crestor

Valsartan 160mg placebo

Drug

Rosuvastatin 20mg Placebo

Drug

Primary outcomes

  1. sitDBP Changes at Week 8 From Baseline

    Time frame: 8 weeks

    sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline

  2. LDL-C Percentage Changes at Week 8 From Baseline

    Time frame: 8 weeks

    LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 7, 2013
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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