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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmitrend®Tab. 80mg; Drug: Telminuvo®Tab. 40/2.5mg

• Registration Number: NCT02231788
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-04
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmitrend®Tab. 80mg	Telmitrend®Tab. 80mg	Telmitrend®Tab.(Telmisartan) 80mg
Telminuvo®Tab. 40/2.5mg	Telminuvo®Tab. 40/2.5mg	Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg

Primary Outcome Measures

Name	Time	Method
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.	Baseline and week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8.	Baseline and week 8	Each timepoint is as following: * Daytime: 06:00\~21:59; * Nighttime: 22:00\~05:59; * Morning: 06:00\~11:59
Change from baseline in the clinic mean blood pressure at week 8.	Baseline and week 8
24hr ABPM and Clinic BP response at week 8.	Baseline and week 8	\<24hr ABPM\> 24hr mean SBP and DBP reduction≥10mmHg; \<Clinic BP\> MSSBP and MSDBP≥10mmHg
24hr ABPM and Clinic BP control at week 8.	Baseline and week 8	\<24hr ABPM\>; * 24hr mean BP: 24hr mean Systolic blood pressure(SBP)\<130mmHg and 24hr mean Diastolic blood pressure(DBP)\<80mmHg; * Daytime BP: Daytime mean SBP\<135mmHg and Daytime mean DBP\<85mmHg; * Night time BP: Night time mean SBP\<120mmHg and Night time mean DBP\<70mmHg; \<Clinic BP\>; : Mean sitting systolic blood pressure(MSSBP)\<140mmHg and Mean sitting diastolic blood pressure(MSDBP)\<90mmHg (If Hypertension with Diabetes mellitus or Chronic kidney disease: MSSBP\<130mmHg and MSDBP\<80mmHg)

Trial Locations

Locations (11)

Bundang Cha Hospital; 🇰🇷 Seongnam, Bundang-gu, Korea, Republic of

Seoul University Hospital; 🇰🇷 Seoul, Jongro-gu, Korea, Republic of

Kumi cha Hospital; 🇰🇷 Gumi, Gyeongsangbuk-do, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Gyeonggi-do, Ansan-si, Korea, Republic of

Seoul University Bundang Hospital; 🇰🇷 Seongnam, Bundang-gu, Korea, Republic of

KyungHee University Medical Center; 🇰🇷 Seoul, Dongdaemun-gu, Korea, Republic of

National Medical Center; 🇰🇷 Seoul, Jung-gu, Korea, Republic of

Hallym University Kangnam Sacred Heart Hosipital; 🇰🇷 Seoul, Yeongdeungpo-gu, Korea, Republic of

Jeju National University Hospital; 🇰🇷 Jeju, Aran, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Seo-gu, Korea, Republic of