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

NCT01918332 | Completed Phase 3 Results

• 1 other identifier: LG-VRCL002
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension,; Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• sitDBP Changes at Week 8 From Baseline

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

  8 weeks

• LDL-C Percentage Changes at Week 8 From Baseline

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

  8 weeks

Study Arms (4)

Valsartan 160mg, Rosuvastatin 20mg

EXPERIMENTAL

Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.

Drug: Valsartan 160mg; Drug: Rosuvastatin 20mg

Valsartan 160mg, Rosuvastatin 20mg placebo

ACTIVE COMPARATOR

Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.

Drug: Valsartan 160mg; Drug: Rosuvastatin 20mg placebo

Valsartan 160mg placebo, Rosuvastatin 20mg

ACTIVE COMPARATOR

Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.

Drug: Rosuvastatin 20mg; Drug: Valsartan 160mg placebo

Placebo

PLACEBO COMPARATOR

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

Interventions

Valsartan 160mg DRUG

Also known as: Diovan

Valsartan 160mg, Rosuvastatin 20mg; Valsartan 160mg, Rosuvastatin 20mg placebo

Rosuvastatin 20mg DRUG

Also known as: Crestor

Valsartan 160mg placebo, Rosuvastatin 20mg; Valsartan 160mg, Rosuvastatin 20mg

Valsartan 160mg placebo DRUG

Placebo; Valsartan 160mg placebo, Rosuvastatin 20mg

Rosuvastatin 20mg placebo DRUG

Placebo; Valsartan 160mg, Rosuvastatin 20mg placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Yonsei University Health System Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Interventions

Valsartan; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Limitations and Caveats

Withdrawal(discontinuation) leading to smaller number of per-protocol set than full analysis set. The violation of protocol was the criterion of subjects' withdrawal.

Results Point of Contact

• Title: Prof. YangSoo Jang
• Organization: Yonsei University Healthcare System Severance Hospital

yejung@lgls.com

82-2-6924-3109

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 7, 2013
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 15, 2014
• Results First Posted: December 15, 2014

Record last verified: 2014-12

Locations

KR (1)