Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738632
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

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

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Telmisartan/Amlodipine+Hydrochlorothiazide Drug: Telmisartan/Amlodipine Drug: Placebo for Hydrochlorothiazide Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telmisartan/Amlodipine+Hydrochlorothiazide
Telmisartan/Amlodipine combination drug and Hydrochlorothiazide
Drug: Telmisartan/Amlodipine+Hydrochlorothiazide

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


Active Comparator: Telmisartan/Amlodipine
Telmisartan/Amlodipine combination drug and Placebo for Hydrochlorothiazide
Drug: Telmisartan/Amlodipine

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


Drug: Placebo for Hydrochlorothiazide



Primary Outcome Measures :
  1. The change of sitting systolic blood pressure [ Time Frame: From baseline at week 8 ]

Secondary Outcome Measures :
  1. The change of sitting systolic blood pressure [ Time Frame: From baseline at week 2 ]
  2. The change of sitting diastolic blood pressure [ Time Frame: From baseline at week 2 and 8 ]
  3. The ratio of subjects who get normalized blood pressure [ Time Frame: at week 2 and 8 ]
  4. Response Rate [ Time Frame: at week 2 and 8 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 19 years old or above Koreans living in Korea
  2. Patients with uncontrolled essential hypertension at screening time(Visit 1)

    • Naïve: 160 mmHg ≤ sitSBP < 200 mmHg
    • Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg
  3. Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2)

    - 140 mmHg ≤ sitSBP < 200 mmHg

  4. Patients who agreed to participate in the trial

Exclusion Criteria:

  1. 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
  2. Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma)
  3. -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
  4. Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
  5. Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c > 9%
  6. Patients who have history of severe or malignant retinopathy within 6 months prior to study entry
  7. 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)
  8. 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)
  9. Patients who should be administered medications prohibited for concomitant use during study period
  10. Patients who are dependent on drugs or alcohol
  11. Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion
  12. Patients with hypersensitivity to the components of investigational drug.
  13. Patients with hypersensitivity to Sulfonamide
  14. Patients with anuria
  15. Patients with hypercalcemia, hyponatremia/hypokalemia
  16. Patients with Addison's disease
  17. Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  18. Patients with any chronic or accute inflammation disease needed to chronic inflammation therapy
  19. History of malignant tumor including leukemia, lymphoma within 5 years
  20. Patients taking other clinical trial drugs within 30 days from the time of visit for screening
  21. Pregnancy, breast-feeding, or child-bearing potential Patients
  22. Patients who are judged unsuitable to participate in this study by investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738632


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02738632     History of Changes
Other Study ID Numbers: ID-TAH-301
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydrochlorothiazide
Telmisartan
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists