Efficacy and Safety of TAH Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients

NCT02738632 | Completed Phase 3

• 1 other identifier: ID-TAH-301
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by Telmisartan/Amlodipine Combination

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• The change of sitting systolic blood pressure

  From baseline at week 8

Secondary Outcomes (4)

• The change of sitting systolic blood pressure

  From baseline at week 2

• The change of sitting diastolic blood pressure

  From baseline at week 2 and 8

• The ratio of subjects who get normalized blood pressure

  at week 2 and 8

• Response Rate

  at week 2 and 8

Study Arms (2)

Telmisartan/Amlodipine+Hydrochlorothiazide

EXPERIMENTAL

Telmisartan/Amlodipine combination drug and Hydrochlorothiazide

Drug: Telmisartan/Amlodipine+Hydrochlorothiazide

Telmisartan/Amlodipine

ACTIVE COMPARATOR

Telmisartan/Amlodipine combination drug and Placebo for Hydrochlorothiazide

Drug: Telmisartan/Amlodipine; Drug: Placebo for Hydrochlorothiazide

Interventions

Telmisartan/Amlodipine+Hydrochlorothiazide DRUG

Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg 1 Tab.QD

Telmisartan/Amlodipine+Hydrochlorothiazide

Telmisartan/Amlodipine DRUG

Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg Placebo 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg Placebo 1 Tab.QD

Telmisartan/Amlodipine

Placebo for Hydrochlorothiazide DRUG

Telmisartan/Amlodipine

Eligibility Criteria

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

You may qualify if:

• years old or above Koreans living in Korea
• Patients with uncontrolled essential hypertension at screening time(Visit 1)
• Naïve: 160 mmHg ≤ sitSBP \< 200 mmHg
• Use antihypertensive drugs:140 mmHg ≤ sitSBP \< 200 mmHg
• Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2)
• \- 140 mmHg ≤ sitSBP \< 200 mmHg
• Patients who agreed to participate in the trial

You may not qualify if:

• Test results showing the following values at screening time(Visit 1)
• The change of mean sitSBP ≥ 20 mmHg or sitDBP ≥ 10 mmHg on target arm between 1st and 2nd measurement
• screening time(Visit 1), time of randomization(Visit 2): sitDBP ≥ 120 mmHg
• Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma)
• Patients with congestive heart failure(NYHA class III\~IV)
• Patients with unstable angina or myocardial infarction or valvular heart disease within 6 months prior to study entry
• Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia
• Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
• Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c \> 9%
• Patients who have history of severe or malignant retinopathy within 6 months prior to study entry
• Patients who suspected of Renal dysfunction that may affect the absorption, distribution, metabolism or excretion (Serum Creatinine :\> 2mg/dL ), gastrointestinal, haematological, liver disease (AST or ALT \> 2.5 times of upper limit of normal range)
• Patients who should be administered antihypertensive drugs other than clinical trial medication(Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators)
• Patients who should be administered medications prohibited for concomitant use during study period
• Patients who are dependent on drugs or alcohol
• Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Sung KC, Oh YS, Cha DH, Hong SJ, Won KH, Yoo KD, Rha SW, Ahn YK, Ahn JC, Jang JY, Hong TJ, Cho SK, Park SH, Hyon MS, Nam CW, Chae IH, Yoo BS, Song JM, Jeong JO, Yoon YW, Kim BS, Yang TH, Cho DK, Kim SH, Choi YJ, Ahn JH, Jeon DW, Kim HS. Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine: The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study. Clin Ther. 2018 Jan;40(1):50-63.e3. doi: 10.1016/j.clinthera.2017.11.006. Epub 2017 Dec 14.

  PMID: 29248384 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

Telmisartan; telmisartan amlodipine combination; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Hypertension; 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; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: May 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 25, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)