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 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    217
The 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
Study Started
Jun 30
2014
Primary Completion
Mar 31
2018
Study Completion
Mar 31
2018
Last Update
Jan 31
2020

Drug Telminuvo®Tab. 40/2.5mg

Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg

  • Other names: Telmisartan/S-Amlodipine 40/2.5mg

Drug Telmitrend®Tab. 80mg

Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg

  • Other names: Telmisartan 80mg

Telminuvo®Tab. 40/2.5mg Experimental

Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg

Telmitrend®Tab. 80mg Active Comparator

Telmitrend®Tab.(Telmisartan) 80mg

Criteria

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
No Results Posted