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

NCT02231788 | Completed Phase 4

• 1 other identifier: 330HT13010
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Hypertension

Keywords

Telminuvo; Telmitrend; Hypertension; 24hr ABPM; Telmisartan; S-amlodipine

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.

  Baseline and week 8

Secondary Outcomes (4)

• Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8.

  Baseline and week 8

• Change from baseline in the clinic mean blood pressure at week 8.

  Baseline and week 8

• 24hr ABPM and Clinic BP control at week 8.

  Baseline and week 8

• 24hr ABPM and Clinic BP response at week 8.

  Baseline and week 8

Study Arms (2)

Telminuvo®Tab. 40/2.5mg

EXPERIMENTAL

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

Drug: Telminuvo®Tab. 40/2.5mg

Telmitrend®Tab. 80mg

ACTIVE COMPARATOR

Telmitrend®Tab.(Telmisartan) 80mg

Drug: Telmitrend®Tab. 80mg

Interventions

Telminuvo®Tab. 40/2.5mg DRUG

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

Also known as: Telmisartan/S-Amlodipine 40/2.5mg

Telminuvo®Tab. 40/2.5mg

Telmitrend®Tab. 80mg DRUG

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

Also known as: Telmisartan 80mg

Telmitrend®Tab. 80mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 19 years in hypertension patient
• 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
• Patient who decided to participate and signed on an informed consent form willingly

You may not qualify if:

• Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg at the time of Screening and Randomization
• As night workers who sleep during the day and whose working hours including 00:00 to 04:00
• Abnormal laboratory test results
• Aspartate aminotransferase/Alanine aminotransferase \> Upper normal limit X 3
• Serum creatinine \> Upper normal limit X 4
• Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc.
• 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
• Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
• Patient who is planning for a renal transplantation during the trial
• Severe or malignant retinopathy
• Acute of chronic inflammatory status requiring treatment
• A history of cancer within five years
• A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
• Severe hypersensitivity to amlodipine or telmisartan
• Surgical or medical conditions

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (11)

Korea University Ansan Hospital

Gyeonggi-do, Ansan-si, South Korea

Location

Jeju National University Hospital

Jeju City, Aran, South Korea

Location

Bundang Cha Hospital

Seongnam, Bundang-gu, South Korea

Location

Seoul University Bundang Hospital

Seongnam, Bundang-gu, South Korea

Location

KyungHee University Medical Center

Seoul, Dongdaemun-gu, South Korea

Location

Gangnam Severance Hospital

Seoul, Gangnam-gu, South Korea

Location

Kumi cha Hospital

Gumi, Gyeongsangbuk-do, South Korea

Location

Seoul University Hospital

Seoul, Jongro-gu, South Korea

Location

National Medical Center

Seoul, Jung-gu, South Korea

Location

Kosin University Gospel Hospital

Busan, Seo-gu, South Korea

Location

Hallym University Kangnam Sacred Heart Hosipital

Seoul, Yeongdeungpo-gu, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35227313 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hyo-Soo Kim, Professor

  Seoul University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2014
• First Posted: September 4, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 31, 2020

Record last verified: 2018-03

Locations

KR (11)