The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy (TENUVA-BP)

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Telminuvo®Tab. 40/2.5mg; Drug: Telmitrend®Tab. 80mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02231788

330HT13010

Details and patient eligibility

About

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

Full 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

Enrollment: 217 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

217 participants in 2 patient groups

Telminuvo®Tab. 40/2.5mg

Experimental group

Description:

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

Treatment:

Drug: Telminuvo®Tab. 40/2.5mg

Telmitrend®Tab. 80mg

Active Comparator group

Description:

Telmitrend®Tab.(Telmisartan) 80mg

Treatment:

Drug: Telmitrend®Tab. 80mg