Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled

Launched by CHONG KUN DANG PHARMACEUTICAL · Aug 17, 2015

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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