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

Chong Kun Dang

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: Telminuvo®Tab. 40/2.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02526875

330HT14009

Details and patient eligibility

About

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

Full description

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

Enrollment: 208 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

night

Experimental group

Description:

Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 pm to 10 pm, Per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg

Treatment:

Drug: Telminuvo®Tab. 40/2.5mg

morning

Active Comparator group

Description:

Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 am to 10 am, Per oral for 8weeks after 2\~4weeks run-in period with Telmitrend®Tab. 40mg

Treatment:

Drug: Telminuvo®Tab. 40/2.5mg