Clinical trial NCT02231788: The Efficacy of a Combination of Telmisartan/S-Amlodipine 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Telminuvo
Telmitrend
Hypertension
24hr ABPM
Telmisartan
S-amlodipine
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 217
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8.
timeFrame: Baseline and week 8
measure: Change from baseline in the clinic mean blood pressure at week 8.
timeFrame: Baseline and week 8
measure: 24hr ABPM and Clinic BP control at week 8.
timeFrame: Baseline and week 8
measure: 24hr ABPM and Clinic BP response at week 8.
timeFrame: Baseline and week 8
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Ansan-si
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
state: Aran
city: Seongnam
country: Korea, Republic of
facility: Bundang Cha Hospital
state: Bundang-gu
city: Seongnam
country: Korea, Republic of
facility: Seoul University Bundang Hospital
state: Bundang-gu
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: Gangnam-gu
city: Gumi
country: Korea, Republic of
facility: Kumi cha Hospital
state: Gyeongsangbuk-do
city: Seoul
country: Korea, Republic of
facility: Seoul University Hospital
state: Jongro-gu
city: Seoul
country: Korea, Republic of
facility: National Medical Center
state: Jung-gu
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Seo-gu
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hosipital
state: Yeongdeungpo-gu
Study officials:
affiliation: Seoul University Hospital
name: Hyo-Soo Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.