NCT03536598

Brief Summary

To evaluate the safety and efficacy of CJ-30060 compared with amlodipine/valsartan combination therapy and valsartan/rosuvastatin combination therapy in hypertensive patients with hyperlipidemia

Trial Health

100
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

October 14, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
Last Updated

May 30, 2018

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

July 18, 2017

Last Update Submit

May 28, 2018

Conditions

Hypertension With Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Change of LDL-C and siSBP

    Mean change from baseline in LDL-C and siSBP at Week 8

    baseline and 8 weeks

Study Arms (3)

Test

EXPERIMENTAL

Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg

Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg

Reference 1

ACTIVE COMPARATOR

Amlodipine 10mg + Valsartan 160mg

Drug: Amlodipine 10 mg + Valsartan 160 mg

Reference 2

ACTIVE COMPARATOR

Valsartan 160mg + Rosuvastatin 20mg

Drug: Valsartan 160 mg + Rosuvastatin 20 mg

Interventions

Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mgDRUG
Test
Amlodipine 10 mg + Valsartan 160 mgDRUG
Reference 1
Valsartan 160 mg + Rosuvastatin 20 mgDRUG
Reference 2

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 19 and 74 years
  • Patient with dyslipidemia and hypertension

You may not qualify if:

  • At screening, siSBP ≥ 200 mmHg or siDBP ≥ 120mmHg or LDL-C \> 250mg/dL or TG ≥ 400mg/dL
  • At screening, siSBP difference is ≥ 20 mmHg or siDBP difference is ≥10 mmHg
  • Secodary hypertension
  • Type I or uncontrolled diabetes mellitus (HbA1c ≥ 9 %)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AmlodipineValsartanRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesAzolesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • Dong Ju Choi, Ph.D

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 18, 2017

First Posted

May 24, 2018

Study Start

October 14, 2016

Primary Completion

September 4, 2017

Study Completion

September 4, 2017

Last Updated

May 30, 2018

Record last verified: 2017-07