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

Sponsor

Daewoong Pharmaceutical Co. LTD. (Industry)

Overall Status

Completed

CT.gov ID

NCT03009487

Collaborator

(none)

265

Enrollment

Location

Arms

14.9

Actual Duration (Months)

17.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Hyperlipidemias	Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg Drug: Olmesartan 40 mg, Rosuvastatin 20mg Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

265 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amlodpine, Olmesartan, Rosuvastatin co-administration of Olmesartan, Amlodipine and Rosuvastatin	Drug: Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg
Placebo Comparator: Olmesartan, Rosuvastatin co-administration of Olmesartan and Rosuvastatin	Drug: Olmesartan 40 mg, Rosuvastatin 20mg co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).
Placebo Comparator: Amlodipine, Olmesartan co-administration of Amlodipine and and Olmesartan	Drug: Amlodipine/Olmesartan 10/40mg (Combination drug) co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg

Arm

Intervention/Treatment

Experimental: Amlodpine, Olmesartan, Rosuvastatin

co-administration of Olmesartan, Amlodipine and Rosuvastatin

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

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

Placebo Comparator: Olmesartan, Rosuvastatin

co-administration of Olmesartan and Rosuvastatin

Drug: Olmesartan 40 mg, Rosuvastatin 20mg

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

Placebo Comparator: Amlodipine, Olmesartan

co-administration of Amlodipine and and Olmesartan

Drug: Amlodipine/Olmesartan 10/40mg (Combination drug)

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

Outcome Measures

Primary Outcome Measures

the change of sitSBP based on baseline between Treatment arm and control 1 arm [8 weeks]
the change of LDL-C based on baseline between Treatment arm and control2 arm [8 weeks]