NCT03009487

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

December 12, 2016

Last Update Submit

December 20, 2021

Conditions

HypertensionHyperlipidemias

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Amlodpine, Olmesartan, Rosuvastatin

EXPERIMENTAL

co-administration of Olmesartan, Amlodipine and Rosuvastatin

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

Olmesartan, Rosuvastatin

PLACEBO COMPARATOR

co-administration of Olmesartan and Rosuvastatin

Drug: Olmesartan 40 mg, Rosuvastatin 20mg

Amlodipine, Olmesartan

PLACEBO COMPARATOR

co-administration of Amlodipine and and Olmesartan

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

Interventions

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

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

Amlodpine, Olmesartan, Rosuvastatin
Olmesartan 40 mg, Rosuvastatin 20mgDRUG

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

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

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

Amlodipine, Olmesartan

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20 to 80 years
  • patients with hypertension and hyperlipidemias

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university bundang hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

AmlodipineolmesartanDrug CombinationsRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPharmaceutical PreparationsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

January 4, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

January 11, 2022

Record last verified: 2021-12

Locations

KR(1)