CompletedNCT03536598Updated May 30, 2018

Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia

A Phase 3 interventional study of Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg and Amlodipine 10 mg + Valsartan 160 mg in Hypertension With Hyperlipidemia, sponsored by HK inno.N Corporation. Completed. Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2018-05-30.

Sponsored by HK inno.N Corporation · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Oct 2016, registered Jul 2017).

Phase: Phase 3
Study type: Interventional
Enrollment: 203
Allocation: Randomized
Ages: 19 Years to 74 Years
Sex: All

Study 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

Conditions studied

Hypertension With Hyperlipidemia

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In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 203 is above the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

HK inno.N Corporation is the lead sponsor of 99 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 74 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Aged between 19 and 74 years
Patient with dyslipidemia and hypertension

Exclusion criteria

Exclusion Criteria:

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 %)

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 203 participants (actual)

Study arms

Experimental
Test
Amlodipine 10mg + Valsartan 160mg + Rosuvastatin 20mg
Drug: Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg
Active comparator
Reference 1
Amlodipine 10mg + Valsartan 160mg
Drug: Amlodipine 10 mg + Valsartan 160 mg
Active comparator
Reference 2
Valsartan 160mg + Rosuvastatin 20mg
Drug: Valsartan 160 mg + Rosuvastatin 20 mg

Interventions

DrugAmlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg
DrugAmlodipine 10 mg + Valsartan 160 mg
DrugValsartan 160 mg + Rosuvastatin 20 mg

What researchers measure

Primary outcomes

Change of LDL-C and siSBP
Mean change from baseline in LDL-C and siSBP at Week 8
Time frame: baseline and 8 weeks

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03536598
Lead sponsor: HK inno.N Corporation
Responsible party: Sponsor
First posted: May 24, 2018
Start date: Oct 14, 2016
Primary completion: Sep 4, 2017
Completion: Sep 4, 2017
Last update: May 30, 2018

Study contacts

Dong Ju Choi, Ph.D

principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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