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

NCT ID: NCT02231788

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-03-31

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 with Telmisartan Monotherapy

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telminuvo®Tab. 40/2.5mg

Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg

Group Type: EXPERIMENTAL

Telminuvo®Tab. 40/2.5mg

Intervention Type: DRUG

Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg

Telmitrend®Tab. 80mg

Telmitrend®Tab.(Telmisartan) 80mg

Group Type: ACTIVE_COMPARATOR

Telmitrend®Tab. 80mg

Intervention Type: DRUG

Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg

Interventions

Telminuvo®Tab. 40/2.5mg

Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg

Intervention Type: DRUG

Telmitrend®Tab. 80mg

Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg

Intervention Type: DRUG

Other Intervention Names

Telmisartan/S-Amlodipine 40/2.5mg; Telmisartan 80mg

Eligibility 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-Ⅱ 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyo-Soo Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul University Hospital

Locations

Korea University Ansan Hospital

Gyeonggi-do, Ansan-si, South Korea

Jeju National University Hospital

Jeju City, Aran, South Korea

Bundang Cha Hospital

Seongnam, Bundang-gu, South Korea

Seoul University Bundang Hospital

Seongnam, Bundang-gu, South Korea

KyungHee University Medical Center

Seoul, Dongdaemun-gu, South Korea

Gangnam Severance Hospital

Seoul, Gangnam-gu, South Korea

Kumi cha Hospital

Gumi, Gyeongsangbuk-do, South Korea

Seoul University Hospital

Seoul, Jongro-gu, South Korea

National Medical Center

Seoul, Jung-gu, South Korea

Kosin University Gospel Hospital

Busan, Seo-gu, South Korea

Hallym University Kangnam Sacred Heart Hosipital

Seoul, Yeongdeungpo-gu, South Korea

Countries

South Korea

References

Kim BJ, Cho KI, Kwon HM, Choi SM, Yoon CH, Lim SW, Joo SJ, Lee NH, Lim SY, Lim SH, Kim HS. Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study. Clin Hypertens. 2022 Mar 1;28(1):7. doi: 10.1186/s40885-021-00184-0.

Reference Type: DERIVED

PMID: 35227313 (View on PubMed)

Other Identifiers

330HT13010

Identifier Type: -

Identifier Source: org_study_id