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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences
ClinicalTrials.gov Identifier:
NCT01918332
First received: August 5, 2013
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Hypertension,
Hyperlipidemia
Drug: Valsartan 160mg
Drug: Rosuvastatin 20mg
Drug: Valsartan 160mg placebo
Drug: Rosuvastatin 20mg placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by LG Life Sciences:

Primary Outcome Measures:
  • sitDBP changes at Week 8 from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    sitDBP changes of the valsartan+rosuvastatin and rosuvastatin alone groups at Week 8 from baseline

  • LDL-C percentage changes at Week 8 from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    LDL-C percentage changes of the valsartan+rosuvastatin and valsartan alone groups at Week 8 from baseline


Enrollment: 168
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valsartan 160mg, Rosuvastatin 20mg
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
Drug: Valsartan 160mg
Other Name: Diovan
Drug: Rosuvastatin 20mg
Other Name: Crestor
Active Comparator: Valsartan 160mg, Rosuvastatin 20mg placebo
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Drug: Valsartan 160mg
Other Name: Diovan
Drug: Rosuvastatin 20mg placebo
Active Comparator: Valsartan 160mg placebo, Rosuvastatin 20mg
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
Drug: Rosuvastatin 20mg
Other Name: Crestor
Drug: Valsartan 160mg placebo
Placebo Comparator: Placebo
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Drug: Valsartan 160mg placebo Drug: Rosuvastatin 20mg placebo

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 )
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918332

Locations
Korea, Republic of
Yonsei University Health System Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
  More Information

No publications provided

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01918332     History of Changes
Other Study ID Numbers: LG-VRCL002
Study First Received: August 5, 2013
Last Updated: August 26, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Valsartan
Rosuvastatin
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 17, 2014