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Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients | Clinical Trials | Clareo Health

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Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

A Multi-Center, Open Label Study To Evaluate Long Term Safety Of Caduet In Patient With Both Of Hypertension And Hypercholesterolemia, Or With Both Of Angina Pectoris And Hypercholesterolemia

NCT01190007•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3):
•(1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value \< 140/90mmHg at Week 0)
•(2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
•(3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C \< 250 mg/dL, and TG \< 400 mg/dL at Week -2
•Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3):
•(1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value \< 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris
•(2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
•(3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C \< 250 mg/dL, and TG \< 400 mg/dL at Week -2

Exclusion Criteria

•Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure \< 140mmHg and diastolic blood pressure \< 90 mmHg.
•Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated

Locations (20)

Healthcare Corporation MEDOC Medical Dock&Clinic

Nagoya, Aichi-ken, Japan

Beppu Medical Clinic

Dazaifu, Fukuoka, Japan

Morizono medical clinic

Kitakyushu, Fukuoka, Japan

Gakkentoshi Clinic

Nishiku, Fukuoka, Japan

Department of internal gastro-intestinal medicine Ohshima clinic

Sapporo, Hokkaido, Japan

Oofuji Clinic

Amagasaki, Hyōgo, Japan

Mizutani Clinic

Kobe, Hyōgo, Japan

Nada Clinic

Kobe, Hyōgo, Japan

Idaimae-naika Clinic

Kawasaki, Kanagawa, Japan

Sakakibara Clinic, Wakaumekai Medical Corporation

Yokohama, Kanagawa, Japan

Key Dates

Start Date

August 1, 2010

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2012

Last Updated

January 28, 2021

Enrollment

159

ACTUAL participants

Conditions

HypertensionHypercholesterolemiaAngina Pectoris

Interventions

Caduet

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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