The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy

Condition(s) targeted: Hypertension

Intervention: Telminuvo®Tab. 40/2.5mg (Drug); Telmitrend®Tab. 80mg (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Chong Kun Dang Pharmaceutical

Official(s) and/or principal investigator(s):
Hyo-Soo Kim, Professor, Principal Investigator, Affiliation: Seoul University Hospital

Overall contact:
Hyo-Soo Kim, Professor, Phone: +82-10-8393-2424, Email: usahyosoo@gmail.com

The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.

Secondary outcome:

Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8.

Change from baseline in the clinic mean blood pressure at week 8.

24hr ABPM and Clinic BP control at week 8.

24hr ABPM and Clinic BP response at week 8.

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 with Telmisartan Monotherapy

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. More than 19 years in hypertension patient 2. 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 3. Patient who decided to participate and signed on an informed consent form willingly Exclusion Criteria: 1. Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg 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. Abnormal laboratory test results

- Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 3

- Serum creatinine > Upper normal limit X 4

4. Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc. 5. 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 6. Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months 7. Patient who is planning for a renal transplantation during the trial 8. Severe or malignant retinopathy 9. Acute of chronic inflammatory status requiring treatment 10. A history of cancer within five years 11. A history of angioedema with ACE inhibitors or angiotensin-â…¡ receptor blockers 12. Severe hypersensitivity to amlodipine or telmisartan 13. 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

14. Need for other antihypertensive drugs during the trial 15. Need for prohibited medication specified in the protocol 16. Administration of other Investigational Product within 30 days 17. History of drug or alcohol abuse within 6 months 18. Pregnant, breast-feeding and childbearing age who don't use adequate contraception 19. Another clinical condition in investigator's judgement

Hyo-Soo Kim, Professor, Phone: +82-10-8393-2424, Email: usahyosoo@gmail.com

Korea University Ansan Hospital, Gyeonggi-do, Ansan-si, Korea, Republic of; Not yet recruiting
Sang Yeop Lim, Professor, Phone: +82-31-412-5366, Email: vnlover@daum.net

Jeju National University Hospital, Jeju, Aran, Korea, Republic of; Recruiting
Seung-Jae Joo, Professor, Phone: +82-64-717-1701, Email: sejjoo@jejunu.ac.kr
Seung-Jae Joo, Professor, Principal Investigator

Bundang Cha Hospital, Seongnam, Bundang-gu, Korea, Republic of; Recruiting
Sang-Uk Lim, Professor, Phone: +82-31-780-5852, Email: swlim@cha.ac.kr
Sang-Uk Lim, Professor, Principal Investigator

Seoul University Bundang Hospital, Seongnam, Bundang-gu, Korea, Republic of; Recruiting
Chang-Hwan Yoon, Professor, Phone: +82-31-787-7032, Email: Kunson2@snu.ac.kr
Chang-Hwan Yoon, Professor, Principal Investigator

KyungHee University Medical Center, Seoul, Dongdaemun-gu, Korea, Republic of; Recruiting
Jin-Bae Kim, Professor, Phone: +82-2-958-8176, Email: jinbbai@khu.ac.kr
Jin-Bae Kim, Professor, Principal Investigator

Gangnam Severance Hospital, Seoul, Gangnam-gu, Korea, Republic of; Recruiting
Hyeok-Mun Kwon, Professor, Phone: +82-2-2019-3310, Email: kwonhm@yuhs.ac
Hyeok-Mun Kwon, Professor, Principal Investigator

Kumi cha Hospital, Gumi, Gyeongsangbuk-do, Korea, Republic of; Recruiting
Hyeon-Sang Lee, Professor, Phone: +82-54-450-9551, Email: phd75602002@daum.net
Hyeon-Sang Lee, Professor, Principal Investigator

Seoul University Hospital, Seoul, Jongro-gu, Korea, Republic of; Recruiting
Hyo-Soo Kim, Professor, Phone: +82-10-8393-2424, Email: usahyosoo@gmail.com
Hyo-Soo Kim, Professor, Principal Investigator

National Medical Center, Seoul, Jung-gu, Korea, Republic of; Recruiting
Seung-Min Choi, Professor, Phone: +82-2-2260-7565, Email: choichoism@gmail.com
Seun-Min Choi, Professor, Principal Investigator

Kosin University Gospel Hospital, Busan, Seo-gu, Korea, Republic of; Not yet recruiting
Hyoung Im Cho, Professor, Phone: +82-51-990-6105, Email: kyoungim74@gmail.com

Sejong Hospital, Bucheon, Wonmi, Korea, Republic of; Recruiting
Yeong-Jin Choi, Professor, Phone: +82-32-340-1433, Email: cyjheart@gmail.com
Yeong-Jin Choi, Professor, Principal Investigator

Hallym University Kangnam Sacred Heart Hosipital, Seoul, Yeongdeungpo-gu, Korea, Republic of; Recruiting
Nam-Ho Lee, Professor, Phone: +82-2-829-5395, Email: Namholee2@hotmail.com
Nam-Ho Lee, Professor, Principal Investigator

Starting date: June 2014
Last updated: August 19, 2015