Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03210532

Enrollment

129

Registered

2017-07-07

Start date

2016-10-07

Completion date

2017-09-30

Last updated

2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypertension

Brief summary

A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia

Interventions

DRUGTelmisartan + Amlodipine + Rosuvastatin

Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo

DRUGTelmisartan + Amlodipine

Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo

DRUGTelmisartan + Rosuvastatin

Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Adults both male and female who are ≥19,\<80 years old * at screening, 140mmHg≤ SBP\<180mmHg & 90mmHg≤ DBP\<110mmHg & LDL-C≤250mg/dL & triglyceride\<400mg/dL

Exclusion criteria

* at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg * secondary hypertension or secondary dyslipidemia * patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease * women who are pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline	8-week
Change of LDL-C(Low Density Lipid Cholesterol) from baseline	8-week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026