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NCT03009487 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03009487
Other study ID # DW_DWJ1351003
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2017
Est. completion date April 2018

Study information
Verified date December 2021
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 265
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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
• 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).
• 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

Locations
Country Name City State
Korea, Republic of Seoul national university bundang hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary the change of sitSBP based on baseline between Treatment arm and control 1 arm 8 weeks
Primary the change of LDL-C based on baseline between Treatment arm and control2 arm 8 weeks
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