NCT03951207

Brief Summary

This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
259

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2019

Typical duration for phase_4

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

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
Last Updated

October 12, 2022

Status Verified

December 1, 2020

Enrollment Period

2.3 years

First QC Date

May 13, 2019

Last Update Submit

October 10, 2022

Conditions

DyslipidemiasHypertension

Outcome Measures

Primary Outcomes (1)

  • Rate of change from baseline to week 8 in LDL-Cholesterol

    Baseline/Week 8

Secondary Outcomes (8)

  • Rate of change from baseline to week 4 in LDL-Cholesterol

    Baseline/Week 4

  • Proportion of subjects who reached the therapeutic goal to week 8

    Week 8

  • Rate of change from baseline to week 4, 8 in lipid profile(without LDL-C)

    Baseline/Week 4, 8

  • Rate of change from baseline to week 4, 8 in hs-CRP

    Baseline/Week 4, 8

  • Rate of change from baseline to week 4, 8 in glucose index

    Baseline/Week 4, 8

  • +3 more secondary outcomes

Study Arms (3)

Rosuampin 10/5mg

EXPERIMENTAL

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Drug: Rosuampin 10/5mg

Rosuampin 20/5mg

EXPERIMENTAL

Rosuvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Drug: Rosuampin 20/5mg

Amlodipine/Atorvastatin 5/20mg

ACTIVE COMPARATOR

Atorvastatin 20mg/Amlodipine 5mg qd for 8 weeks

Drug: Amlodipine/Atorvastatin 5/20mg

Interventions

Rosuampin 10/5mgDRUG

Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks

Rosuampin 10/5mg
Rosuampin 20/5mgDRUG

Rosuampin 20/5mg qd for 8 weeks

Rosuampin 20/5mg
Amlodipine/Atorvastatin 5/20mgDRUG

Amlodipine/Atorvastatin 5/20mg qd for 8 weeks

Amlodipine/Atorvastatin 5/20mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both man and woman who is over 19 years old
  • Patient with dyslipidemia and hypertension
  • Written informed consent

You may not qualify if:

  • Triglyceride ≥ 400 mg/dL at screening
  • Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors
  • sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
  • A history of rhabdomyolysis, myopathy
  • Patient with hypersensitivity to Statin or Amlodipine
  • Patients undergoing eGFR \<30 mL/min/1.73 m2 (MDRD) at screening
  • AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
  • Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range)
  • Contraindications stated in the Label of Rosuampin or Caduet
  • Those participating in other clinical trials for investigational products at screening
  • Patients deemed to be ineligible to participate in the trial by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic Univ. Medical Center

Daegu, South Korea

Location

Related Publications (2)

  • Park CM, Jung HW. Predictors of Significant High-Sensitivity C-Reactive Protein Reduction After Use of Rosuvastatin/Amlodipine and Atorvastatin/Amlodipine-Subgroup Analysis in Randomized Controlled Trials. J Clin Med. 2025 May 12;14(10):3363. doi: 10.3390/jcm14103363.

    PMID: 40429358DERIVED

  • Jung HW, Kim CY, Hong SP, Bae HJ, Choi JY, Ryu JK, Lee JB, Lee KH, Han KR, Yang DH, Park CG, Yu GW, Rhee MY, Park SJ, Hyon MS, Shin JH, Hong BK, Jin HY, Lee SY, Seol SH, Lee SR, Kim SY, Lee KJ, Cho EJ, Nam CW, Park TH, Kim U, Kim KS. Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia. J Clin Hypertens (Greenwich). 2023 Sep;25(9):828-844. doi: 10.1111/jch.14715. Epub 2023 Aug 16.

    PMID: 37584254DERIVED

MeSH Terms

Conditions

DyslipidemiasHypertension

Interventions

AmlodipineAtorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

May 30, 2019

Primary Completion

September 29, 2021

Study Completion

September 29, 2021

Last Updated

October 12, 2022

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)