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

• Sponsor: IlDong Pharmaceutical Co Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02738632
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 19.9

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The change of sitting systolic blood pressure [From baseline at week 8]

Secondary Outcome Measures

1. The change of sitting systolic blood pressure [From baseline at week 2]

2. The change of sitting diastolic blood pressure [From baseline at week 2 and 8]

3. The ratio of subjects who get normalized blood pressure [at week 2 and 8]

4. Response Rate [at week 2 and 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2)

• 140 mmHg ≤ sitSBP < 200 mmHg

1. 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

1. Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma)

2. -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

1. Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry

2. Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c > 9%

3. Patients who have history of severe or malignant retinopathy within 6 months prior to study entry

4. 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)

5. 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)

6. Patients who should be administered medications prohibited for concomitant use during study period

7. Patients who are dependent on drugs or alcohol

8. Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion

9. Patients with hypersensitivity to the components of investigational drug.

10. Patients with hypersensitivity to Sulfonamide

11. Patients with anuria

12. Patients with hypercalcemia, hyponatremia/hypokalemia

13. Patients with Addison's disease

14. Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

15. Patients with any chronic or accute inflammation disease needed to chronic inflammation therapy

16. History of malignant tumor including leukemia, lymphoma within 5 years

17. Patients taking other clinical trial drugs within 30 days from the time of visit for screening

18. Pregnancy, breast-feeding, or child-bearing potential Patients

19. Patients who are judged unsuitable to participate in this study by investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• IlDong Pharmaceutical Co Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IlDong Pharmaceutical Co Ltd
• ClinicalTrials.gov Identifier: NCT02738632
• Other Study ID Numbers: ID-TAH-301
• First Posted: Apr 14, 2016
• Last Update Posted: Nov 25, 2016
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Amlodipine; Hydrochlorothiazide; Telmisartan; Telmisartan amlodipine combination

Study Results

No Results Posted as of Nov 25, 2016