Status:
COMPLETED
The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT02231788
Start Date
June 1 2014
End Date
March 1 2018
Last Update
January 31 2020
Active Locations (11)
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1
Korea University Ansan Hospital
Gyeonggi-do, Ansan-si, South Korea
2
Jeju National University Hospital
Jeju City, Aran, South Korea
3
Bundang Cha Hospital
Seongnam, Bundang-gu, South Korea
4
Seoul University Bundang Hospital
Seongnam, Bundang-gu, South Korea