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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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ClinicalTrials.gov Identifier: NCT03210532
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemia Drug: Telmisartan + Amlodipine + Rosuvastatin Drug: Telmisartan + Amlodipine Drug: Telmisartan + Rosuvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : October 7, 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test
qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)
Drug: Telmisartan + Amlodipine + Rosuvastatin
Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo

Active Comparator: Reference 1
qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)
Drug: Telmisartan + Rosuvastatin
Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo

Active Comparator: Reference 2
qd PO,Twynsta(telmisartan/amlodipine)
Drug: Telmisartan + Amlodipine
Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210532


Locations
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Korea, Republic of
Sevrance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.
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Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03210532    
Other Study ID Numbers: DW1501-301
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Telmisartan
Telmisartan amlodipine combination
Rosuvastatin Calcium
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists