A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. More than 20 years in hypertension patient
2. Hypertension is satisfied with the Clinic blood pressure that was measured at the time of screening
* Treatment-Naive: Clinic Mean sitting diastolic blood pressure ≥ 100mmHg.
* Treatment-Experienced: Clinic Mean sitting diastolic blood pressure ≥ 90mmHg.
3. Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization
* Clinic Mean sitting diastolic blood pressure ≥ 90mmHg
4. Patient who decided to participate and signed on an informed consent form willingly
You may not be if
1. Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg at the time of Screening and Randomization
2. As night workers who sleep during the day and whose working hours including 00:00 to 04:00
3. Secondary Hypertension
4. 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
5. Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
6. type 1 diabetes mellitus or Uncontrolled type 2 diabetes mellitus(HbA1c \> 8.0%)
7. Severe or malignant retinopathy
8. Abnormal laboratory test results
* Aspartate aminotransferase/Alanine aminotransferase \> Upper normal limit X 2
* Serum creatinine \> Upper normal limit X 2
9. Acute of chronic inflammatory status requiring treatment
10. Need for other antihypertensive drugs during the trial
11. Need for prohibited medication specified in the protocol
12. A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
13. Severe hypersensitivity to amlodipine or telmisartan
14. History of drug or alcohol abuse within 6 months
15. 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
16. Administration of other Investigational Product within 30 days
17. Pregnant, breast-feeding and childbearing age who don't use adequate contraception
18. History of malignant tumor within 5 years (including leukemia and lymphoma)
19. Another clinical condition in investigator's judgement
Clareo Health | Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
