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Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment

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ClinicalTrials.gov Identifier: NCT02620163
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:
To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment

Condition or disease Intervention/treatment Phase
Hypertension Drug: telmisartan/amlodipine 40/5mg Drug: YH22162 40/5/12.5 mg Drug: telmisartan/amlodipine 80/5mg Drug: YH22162 80/5/25 mg Drug: telmisartan/amlodipine 40/5mg placebo Drug: YH22162 40/5/12.5 mg placebo Drug: telmisartan/amlodipine 80/5mg placebo Drug: YH22162 80/5/25 mg placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH22162 in Subjects With Essential Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: YH22162
YH22162 40/5/12.5 mg (telmisartan 40/amlodipine 5mg/chlorthalidone 12.5mg) for the first 2 weeks, then force titrated to YH22162(telmisartan 80mg/amlodipine 5mg/chlorthalidone 25mg) for the remaining 6weeks
Drug: YH22162 40/5/12.5 mg
Other Name: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg

Drug: YH22162 80/5/25 mg
Other Name: telmisartan/amlodipine/chlorthalidone 80/5/25 mg

Drug: telmisartan/amlodipine 40/5mg placebo
Other Name: Twynsta 40/5 mg placebo

Drug: telmisartan/amlodipine 80/5mg placebo
Other Name: Twynsta 80/5 mg

Active Comparator: telmisartan/amlodipine
Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks
Drug: telmisartan/amlodipine 40/5mg
Other Name: Twynsta 40/5 mg

Drug: telmisartan/amlodipine 80/5mg
Other Name: Twynsta 80/5 mg

Drug: YH22162 40/5/12.5 mg placebo
Other Name: telmisartan/amlodipine/chlorthalidone 40/5/12.5 mg placebo

Drug: YH22162 80/5/25 mg placebo
Other Name: telmisartan/amlodipine/chlorthalidone 80/5/25 mg placebo




Primary Outcome Measures :
  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 [ Time Frame: baseline and week 8 ]

Secondary Outcome Measures :
  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 [ Time Frame: baseline and week 2 ]
  2. Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 [ Time Frame: baseline and week 4 ]
  3. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 2 [ Time Frame: baseline and week 2 ]
  4. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 4 [ Time Frame: baseline and week 4 ]
  5. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 8 [ Time Frame: baseline and week 8 ]
  6. Patients Achieving Blood Pressure Control at Week 2 [ Time Frame: baseline and week 2 ]
    Mean sitting blood pressure(MSBP) < 140/90 mmHg

  7. Patients Achieving Blood Pressure Control at Week 4 [ Time Frame: baseline and week 4 ]
    Mean sitting blood pressure(MSBP) < 140/90 mmHg

  8. Patients Achieving Blood Pressure Control at Week 8 [ Time Frame: baseline and week 8 ]
    Mean sitting blood pressure(MSBP) < 140/90 mmHg

  9. Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 2 [ Time Frame: baseline and week 2 ]
    reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg

  10. Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 4 [ Time Frame: baseline and week 4 ]
    reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg

  11. Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 8 [ Time Frame: baseline and week 8 ]
    reduction of MSSBP>= 20 mmHg and reduction of MSSBP>= 10 mmHg



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

Inclusion Criteria:

  • Signed Informed Consent
  • Men and women ≥ 19 years of age
  • Essential hypertensive patients

    1. If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP < 200 mmHg
    2. If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP < 200 mmHg

Exclusion Criteria:

  • Patients with known or suspected secondary hypertension
  • Other exclusions applied

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): NCT02620163


Locations
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Korea, Republic of
Yuhan
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Study Director: Hyunhee Na, MD Yuhan Corporation

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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02620163     History of Changes
Other Study ID Numbers: YH22162-301
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Chlorthalidone
Telmisartan amlodipine combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors