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

Primary Purpose

Hypertension,, Hyperlipidemia

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Valsartan 160mg

Rosuvastatin 20mg

Valsartan 160mg placebo

Rosuvastatin 20mg placebo

About this trial

This is an interventional treatment trial for Hypertension,

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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 )

Sites / Locations

Yonsei University Health System Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Valsartan 160mg, Rosuvastatin 20mg

Valsartan 160mg, Rosuvastatin 20mg placebo

Valsartan 160mg placebo, Rosuvastatin 20mg

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

sitDBP Changes at Week 8 From Baseline

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01918332

First Posted

August 5, 2013

Last Updated

December 8, 2014

Sponsor

LG Life Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01918332

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Life Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension,, Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valsartan 160mg, Rosuvastatin 20mg

Arm Type

Experimental

Arm Description

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

Arm Title

Valsartan 160mg, Rosuvastatin 20mg placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

Valsartan 160mg placebo, Rosuvastatin 20mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Valsartan 160mg

Other Intervention Name(s)

Diovan

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 20mg

Other Intervention Name(s)

Crestor

Intervention Type

Drug

Intervention Name(s)

Valsartan 160mg placebo

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 20mg placebo

Primary Outcome Measure Information:

Title

sitDBP Changes at Week 8 From Baseline

Description

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

Time Frame

8 weeks

Title

LDL-C Percentage Changes at Week 8 From Baseline

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 )

Facility Information:

Facility Name

Yonsei University Health System Severance Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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