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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

August 5, 2013
August 26, 2013
April 2012
March 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01918332 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Efficacy and Safety of Valsartan 160mg and Rosuvastatin 20mg in Patients With Hypertension and Hyperlipidemia
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hypertension,
  • Hyperlipidemia
  • Drug: Valsartan 160mg
    Other Name: Diovan
  • Drug: Rosuvastatin 20mg
    Other Name: Crestor
  • Drug: Valsartan 160mg placebo
  • Drug: Rosuvastatin 20mg placebo
  • Experimental: Valsartan 160mg, Rosuvastatin 20mg
    Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
    Interventions:
    • Drug: Valsartan 160mg
    • Drug: Rosuvastatin 20mg
  • 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.
    Interventions:
    • Drug: Valsartan 160mg
    • 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.
    Interventions:
    • Drug: Rosuvastatin 20mg
    • 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.
    Interventions:
    • Drug: Valsartan 160mg placebo
    • Drug: Rosuvastatin 20mg placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
March 2013
March 2013   (final data collection date for primary outcome measure)

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 )
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01918332
LG-VRCL002
No
LG Life Sciences
LG Life Sciences
Not Provided
Not Provided
LG Life Sciences
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP