DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Hypercholesterolemia; Angina Pectoris

Intervention: Caduet (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary outcome:

Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia

Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia

Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia

Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit

Percent Change From Baseline in Total Cholesterol (TC) at Each Visit

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit

Percent Change From Baseline in Triglyceride (TG) at Each Visit

Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit

Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit

Percent Change From Baseline in Apolipoprotein B at Each Visit

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Yano Cardiovascular Clinic, Fukuoka, Japan

Nakaoka Clinic, Osaka, Japan

Healthcare Corporation MEDOC Medical Dock&Clinic, Nagoya, Aichi, Japan

Beppu Medical Clinic, Dazaifu, Fukuoka, Japan

Morizono medical clinic, Kitakyushu, Fukuoka, Japan

Gakkentoshi Clinic, Nishi-ku, Fukuoka, Japan

Department of internal gastro-intestinal medicine Ohshima clinic, Sapporo, Hokkaido, Japan

Oofuji Clinic, Amagasaki, Hyogo, Japan

Mizutani Clinic, Kobe, Hyogo, Japan

Nada Clinic, Kobe, Hyogo, Japan

Idaimae-naika Clinic, Kawasaki, Kanagawa, Japan

Sakakibara Clinic, Wakaumekai Medical Corporation, Yokohama, Kanagawa, Japan

Masunaga Clinic, Fujimi, Saitama, Japan

Sugiura Clinic, Kawaguchi, Saitama, Japan

Masuda Clinic, Adachi-ku, Tokyo, Japan

Wakasugi Family Clinic, Arakawa-ku, Tokyo, Japan

Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic, Koto-ku, Tokyo, Japan

Banno Clinic, Ohta-ku, Tokyo, Japan

Hatano Medical Clinic, Setagaya-ku, Tokyo, Japan

Suzuki Circulatory Medical Clinic, Setagaya-ku, Tokyo, Japan

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2010
Last updated: December 19, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015