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

NCT03566316 | Completed Phase 3

• 1 other identifier: ID-TAR-301
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension With Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Percentage of change in LDL-Cholesterol

  Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Amlodipine

  From baseline at week 8

• The change of sitting systolic blood pressure

  Telmisartan/Amlodipine/Rosuvastatin versus Telmisartan/Rosuvastatin

  From baseline at week 8

Secondary Outcomes (7)

• Percentage of change in LDL-Cholesterol

  From baseline at week 4

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

  From baseline at week 4 and 8

• The change of HDL-Cholesterol/LDL-Cholesterol ratio

  From baseline at week 4 and 8

• The change of total cholesterol/HDL-Cholesterol ratio

  From baseline at week 4 and 8

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

  From baseline at week 4 and 8

Study Arms (3)

Telmisartan/Amlodipine+Rosuvastatin

EXPERIMENTAL

Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin 20mg1tab. and Telmisartan placebo 1tab.

Drug: Telmisartan/Amlodipine; Drug: Rosuvastatin

Telmisartan/Amlodipine

ACTIVE COMPARATOR

Telmisartan/Amlodipine 40/5mg 2tab., Rosuvastatin placebo 1tab. and Telmisartan placebo 1tab.

Drug: Telmisartan/Amlodipine

Telmisartan +Rosuvastatin

ACTIVE COMPARATOR

Telmisartan/Amlodipine placebo 2tab., Rosuvastatin 80mg 1tab. and Telmisartan 20mg 1tab.

Drug: Rosuvastatin; Drug: Telmisartan

Interventions

Telmisartan/Amlodipine DRUG

Telmisartan/Amlodipine; Telmisartan/Amlodipine+Rosuvastatin

Rosuvastatin DRUG

Telmisartan +Rosuvastatin; Telmisartan/Amlodipine+Rosuvastatin

Telmisartan DRUG

Telmisartan +Rosuvastatin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim TS, Rha SW, Kim SY, Park DG, Sung KC, Yoon MH, Kim KH, Lee HC, Kim WS, Kim YJ, Ahn JC, Rhee MY, Cha DH, Yoo BS, Park SH, Yoo KD, Jeon DW, Yoon YW, Cho SK, Oh YS. Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study. Clin Ther. 2019 Apr;41(4):728-741. doi: 10.1016/j.clinthera.2019.02.013. Epub 2019 Mar 21.

  PMID: 30904178 DERIVED

MeSH Terms

Interventions

telmisartan amlodipine combination; Rosuvastatin Calcium; Telmisartan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 25, 2018
• Study Start: November 24, 2015
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)