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

NCT ID: NCT01918332

Last Updated: 2014-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension, Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Valsartan 160mg, Rosuvastatin 20mg

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

Group Type EXPERIMENTAL

Valsartan 160mg

Intervention Type DRUG

Rosuvastatin 20mg

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Valsartan 160mg

Intervention Type DRUG

Rosuvastatin 20mg placebo

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Rosuvastatin 20mg

Intervention Type DRUG

Valsartan 160mg placebo

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Valsartan 160mg placebo

Intervention Type DRUG

Rosuvastatin 20mg placebo

Intervention Type DRUG

Interventions

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Valsartan 160mg

Intervention Type DRUG

Rosuvastatin 20mg

Intervention Type DRUG

Valsartan 160mg placebo

Intervention Type DRUG

Rosuvastatin 20mg placebo

Intervention Type DRUG

Other Intervention Names

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Diovan Crestor

Eligibility Criteria

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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 )
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University Health System Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LG-VRCL002

Identifier Type: -

Identifier Source: org_study_id