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

• Status: Unknown status
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Amlodipine; Telmisartan

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