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Completed

NCT Number: NCT03210532

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sevrance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan + Amlodipine + Rosuvastatin

Drug

Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo

Telmisartan + Amlodipine

Drug

Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo

Telmisartan + Rosuvastatin

Drug

Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo

Primary outcomes

  1. Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline

    Time frame: 8-week

  2. Change of LDL-C(Low Density Lipid Cholesterol) from baseline

    Time frame: 8-week

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2017
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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