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A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

Primary Purpose

Hypertension, Hyperlipidemias

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg

Olmesartan 40 mg, Rosuvastatin 20mg

Amlodipine/Olmesartan 10/40mg (Combination drug)

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:

Age 20 to 80 years
patients with hypertension and hyperlipidemias

Exclusion Criteria:

orthostatic hypotension
History of ventricular tachycardia, atrial fibrillation
uncontrolled diabetes mellitus

Sites / Locations

Seoul national university bundang hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Amlodpine, Olmesartan, Rosuvastatin

Olmesartan, Rosuvastatin

Amlodipine, Olmesartan

Arm Description

co-administration of Olmesartan, Amlodipine and Rosuvastatin

co-administration of Olmesartan and Rosuvastatin

co-administration of Amlodipine and and Olmesartan

Outcomes

Primary Outcome Measures

the change of sitSBP based on baseline between Treatment arm and control 1 arm

the change of LDL-C based on baseline between Treatment arm and control2 arm

Secondary Outcome Measures

Full Information

NCT ID

NCT03009487

First Posted

December 12, 2016

Last Updated

December 20, 2021

Sponsor

Daewoong Pharmaceutical Co. LTD.

1. Study Identification

Unique Protocol Identification Number

NCT03009487

Brief Title

A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

Official Title

A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daewoong Pharmaceutical Co. LTD.

4. Oversight

5. Study Description

Brief Summary

A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia

6. Conditions and Keywords

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

Hypertension, Hyperlipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

265 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amlodpine, Olmesartan, Rosuvastatin

Arm Type

Experimental

Arm Description

co-administration of Olmesartan, Amlodipine and Rosuvastatin

Arm Title

Olmesartan, Rosuvastatin

Arm Type

Placebo Comparator

Arm Description

co-administration of Olmesartan and Rosuvastatin

Arm Title

Amlodipine, Olmesartan

Arm Type

Placebo Comparator

Arm Description

co-administration of Amlodipine and and Olmesartan

Intervention Type

Drug

Intervention Name(s)

Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg

Intervention Description

co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg

Intervention Type

Drug

Intervention Name(s)

Olmesartan 40 mg, Rosuvastatin 20mg

Intervention Description

co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).

Intervention Type

Drug

Intervention Name(s)

Amlodipine/Olmesartan 10/40mg (Combination drug)

Intervention Description

co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg

Primary Outcome Measure Information:

Title

the change of sitSBP based on baseline between Treatment arm and control 1 arm

Time Frame

8 weeks

Title

the change of LDL-C based on baseline between Treatment arm and control2 arm

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: Age 20 to 80 years patients with hypertension and hyperlipidemias Exclusion Criteria: orthostatic hypotension History of ventricular tachycardia, atrial fibrillation uncontrolled diabetes mellitus

Facility Information:

Facility Name

Seoul national university bundang hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia

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