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Generated: December 9, 2018

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CLINICAL TRIALS PROFILE FOR EXFORGE HCT

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Clinical Trials for Exforge Hct

Trial ID Title Status Sponsor Phase Summary
NCT00523744 Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension Completed Novartis Phase 3 This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).
NCT01070043 To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone Completed Novartis Phase 4 The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.
NCT01167153 Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients Completed Novartis Phase 4 The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.
NCT01494727 Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg Completed CJ HealthCare Corporation Phase 1 The objectives of this study are: - To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers - To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
NCT01735890 Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet Completed CJ HealthCare Corporation Phase 1 The objectives of this study are: - To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers - To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg after a single oral administration in healthy male volunteers
NCT01776047 A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers Completed Dong-A Pharmaceutical Co., Ltd. Phase 1 Study Design : randomized, open label, single-dose, 2-way cross-over design Phase : Phase I
NCT01819779 Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60) Unknown status Hanlim Pharm. Co., Ltd. Phase 1 The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a combination formulation of valsartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Exforge Hct

Condition Name

Condition Name for Exforge Hct
Intervention Trials
Healthy 6
Hypertension 4
Healthy Male Subjects 1
Essential Hypertension 1
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Condition MeSH

Condition MeSH for Exforge Hct
Intervention Trials
Hypertension 4
Hyperlipidemias 1
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Clinical Trial Locations for Exforge Hct

Trials by Country

Trials by Country for Exforge Hct
Location Trials
Korea, Republic of 6
Taiwan 1
Turkey 1
Germany 1
China 1
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Clinical Trial Progress for Exforge Hct

Clinical Trial Phase

Clinical Trial Phase for Exforge Hct
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 1 9
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Clinical Trial Status

Clinical Trial Status for Exforge Hct
Clinical Trial Phase Trials
Completed 10
Unknown status 3
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Clinical Trial Sponsors for Exforge Hct

Sponsor Name

Sponsor Name for Exforge Hct
Sponsor Trials
CJ HealthCare Corporation 5
Novartis 3
Hanlim Pharm. Co., Ltd. 1
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Sponsor Type

Sponsor Type for Exforge Hct
Sponsor Trials
Industry 12
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cipla
UBS
Merck
US Department of Justice
Express Scripts
Baxter
McKesson
Farmers Insurance

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