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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738632
• Other study ID #: ID-TAH-301
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2016
• Last updated: November 22, 2016
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: IlDong Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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, ß-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, a-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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
• 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
• Placebo for Hydrochlorothiazide

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of sitting systolic blood pressure		From baseline at week 8	No
Secondary	The change of sitting systolic blood pressure		From baseline at week 2	No
Secondary	The change of sitting diastolic blood pressure		From baseline at week 2 and 8	No
Secondary	The ratio of subjects who get normalized blood pressure		at week 2 and 8	No
Secondary	Response Rate		at week 2 and 8	No