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

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ClinicalTrials.gov Identifier: NCT01918332
Recruitment Status : Completed
First Posted : August 7, 2013
Results First Posted : December 15, 2014
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension, Hyperlipidemia Drug: Valsartan 160mg Drug: Rosuvastatin 20mg Drug: Valsartan 160mg placebo Drug: Rosuvastatin 20mg placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918332


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

Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT01918332     History of Changes
Other Study ID Numbers: LG-VRCL002
First Posted: August 7, 2013    Key Record Dates
Results First Posted: December 15, 2014
Last Update Posted: December 15, 2014
Last Verified: December 2014

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