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Completed

NCT Number: NCT03566316

Efficacy/Safety of Telmisartan/Amlodipine/Rosuvastatin in Hypertensive Patients With Hyperlipidemia

A Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients with Hyperlipidemia

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Guro Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 19 years old or above
  • Patients who confirmed essential hypertension with Hyperlipidemia or use of drugs at Visit 1 (sit systolic blood pressure ≥ 140mmHg, LDL-Cholesterol ≥ 100mg/dL)
  • Patients who can stop the treatment of anti-hypertensive/anti-hyperlipidemic drugs in the opinion of the investigator
  • Test results showing the following values at screening time (Visit 2) : sit systolic blood pressure >140mmHg
  • Test results showing the following values at screening time (Visit 2) : 100< LDL-Cholesterol <250
  • Patients who agreed to participate in the trial

Exclusion criteria

  • Severe hypertension patients(systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg)

-The change of mean sit systolic blood pressure ≥ 20 mmHg or sit diastolic blood pressure ≥ 10 mmHg on target arm between 1st and 2nd measurement

  • LDL-Cholesterol > 250 mg/dL or triacylglycerol ≥ 400 mg/dL at screening time(Visit 1)
  • Patients with postural hypotension who have sign and symptom
  • Patients with secondary blood pressure(for example,aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, Polycystic Kidney Diseases)
  • Patients with congestive heart failure(New York Heart Association class III~IV)
  • Patients with history of acute coronary syndrome or underwent revascularization (percutaneous transluminal coronary angioplasty or Coronary Artery Bypass Graft surgery ) within 6 months
  • Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia
  • Causes of hemodynamic disorder or structural heart defect such as valvular heart disease
  • Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
  • Patients with primary aldosteronism
  • Patients with severe ocular disorders
  • Patients with autoimmune disease
  • Patients with any chronic inflammation disease needed to chronic inflammation therapy
  • Patients with uncontrolled diabetes Mellitus with HbA1c > 9% or thyroid diseases(TSH ≥ 1.5 X ULN)
  • Patients who have a history of myopathy or rhabdomyolysis
  • Patients who have 3 times of upper limit of normal range of muscle enzyme (creatinine kinase, CK)
  • History of malignant tumor including leukemia, lymphoma within 5 years
  • Patients with one kidney
  • Patients with biliary obstructive disorder
  • Patients with clinically significant electrolyte disturbance
  • Continued serum potassium concentration abnormal status (<3.5mEq/L or >5.5mEq/L)
  • Patients with sodium ion or body fluid is depleted and not able to correct
  • Patients with clinically significant liver/renal disease
  • Patients with digestive diseases that may affect the absorption or history in gastrointestinal surgery
  • Patients who are dependent on drugs or alcohol
  • Pregnancy, breast-feeding, or child-bearing potential Patients
  • Patients with hypersensitivity to telmisartan or other angiotensin II receptor blockers
  • Patients with hypersensitivity to Amlodipine or other dihydropyridine drugs
  • Patients with history of Myotoxicity to other 3-hydroxy-methyl glutaryl-coenzyme A reductase inhibitor or fibrate
  • Patients who are unable to stop taking prohibited drugs to combination during study period
  • Patients who have galactose intolerance
  • Patients taking other clinical trial drugs within 30 days from the time of visit for screening
  • Patients that is not eligible to participate at the discretion of study investigator

Treatment and study plan

Telmisartan/Amlodipine

Drug

Rosuvastatin

Drug

Telmisartan

Drug

Primary outcomes

  1. Percentage of change in LDL-Cholesterol

    Time frame: From baseline at week 8

    Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine

  2. The change of sitting systolic blood pressure

    Time frame: From baseline at week 8

    Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin

Secondary outcomes

  1. Percentage of change in LDL-Cholesterol

    Time frame: From baseline at week 4

  2. Percentage of change in HDL-Cholesterol, total Cholesterol, Triglyceride, Apolipoprotein B

    Time frame: From baseline at week 4 and 8

  3. The change of HDL-Cholesterol/LDL-Cholesterol ratio

    Time frame: From baseline at week 4 and 8

  4. The change of total cholesterol/HDL-Cholesterol ratio

    Time frame: From baseline at week 4 and 8

  5. Percentage of patients reaching treatment goals according to National Cholesterol Education Program-Adults Treatment Panel III Guideline

    Time frame: From baseline at week 4 and 8

  6. The change of sitting diastolic blood pressure

    Time frame: From baseline at week 4 and 8

  7. Percentage of patients reaching treatment goals according to Joint National Committee VIII Guideline

    Time frame: From baseline at week 4 and 8

Sponsors and collaborators

Lead sponsor

IlDong Pharmaceutical Co Ltd

Industry

Registry information

Official study title

Randomized, Double-blind, Multi-center Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine and Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 25, 2018
Registry last updated
Jun 25, 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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