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NCT03210532 Clinical Trial

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

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03210532
Other study ID # DW1501-301
Secondary ID
Status Completed
Phase Phase 3
First received October 12, 2016
Last updated January 30, 2018
Start date October 7, 2016
Est. completion date September 2017

Study information
Verified date January 2018
Source Daewon Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 79 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Telmisartan + Amlodipine + Rosuvastatin
Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo
• Telmisartan + Amlodipine
Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo
• Telmisartan + Rosuvastatin
Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo

Locations
Country Name City State
Korea, Republic of Sevrance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

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