Title
The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial to Evaluate the Efficacy of Telmisartan/S-Amlodipine(Telminuvo® Tab. 40/2.5mg) on 24-hour Ambulatory BP Control Compared With Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Phase
Phase 4Lead Sponsor
Chong Kun Dang PharmaceuticalStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HypertensionIntervention/Treatment
amlodipine telmisartan ...Study Participants
217The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg
Inclusion Criteria: More than 19 years in hypertension patient Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization Clinic MSSBP ≥ 140mmHg Clinic MSSBP ≥ 130mmHg in diabetes mellitus or chronic kidney disease Diabetes mellitus Before screening, diagnosed with diabetes mellitus being treated with oral hypoglycemic agents at least 30 days OR Patients who meet the following results of laboratory tests at the time of randomization. : Fasting plasma glucose ≥ 126mg/dL Chronic kidney disease Patients who meet the following results of laboratory tests at the time of randomization.: 15mL/min/1.73m2 ≤ estimated glomerular filtration rate ≤ 60mL/min/1.73m2 Patient who decided to participate and signed on an informed consent form willingly Exclusion Criteria: Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg at the time of Screening and Randomization As night workers who sleep during the day and whose working hours including 00:00 to 04:00 Abnormal laboratory test results Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 3 Serum creatinine > Upper normal limit X 4 Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc. Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months Patient who is planning for a renal transplantation during the trial Severe or malignant retinopathy Acute of chronic inflammatory status requiring treatment A history of cancer within five years A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers Severe hypersensitivity to amlodipine or telmisartan Surgical or medical conditions History of major gastrointestinal surgery History of active inflammatory bowel syndrome within 12 months Abnormal pancreatic functions Gastrointestinal/rectal bleeding Urinary tract obstruction Need for other antihypertensive drugs during the trial Need for prohibited medication specified in the protocol Administration of other Investigational Product within 30 days History of drug or alcohol abuse within 6 months Pregnant, breast-feeding and childbearing age who don't use adequate contraception Another clinical condition in investigator's judgement