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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190007
• Other study ID #: A3841064
• Status: Completed
• Phase: Phase 4
• Start date: August 2010
• Est. completion date: February 2012

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Hypercholesterolemia
• Hypertension

Intervention

Drug:
• Caduet
One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks

Locations

Country	Name	City	State
Japan	Masuda Clinic	Adachi-ku	Tokyo
Japan	Oofuji Clinic	Amagasaki	Hyogo
Japan	Wakasugi Family Clinic	Arakawa-ku	Tokyo
Japan	Beppu Medical Clinic	Dazaifu	Fukuoka
Japan	Masunaga Clinic	Fujimi	Saitama
Japan	Yano Cardiovascular Clinic	Fukuoka
Japan	Sugiura Clinic	Kawaguchi	Saitama
Japan	Idaimae-naika Clinic	Kawasaki	Kanagawa
Japan	Morizono medical clinic	Kitakyushu	Fukuoka
Japan	Mizutani Clinic	Kobe	Hyogo
Japan	Nada Clinic	Kobe	Hyogo
Japan	Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic	Koto-ku	Tokyo
Japan	Healthcare Corporation MEDOC Medical Dock&Clinic	Nagoya	Aichi
Japan	Gakkentoshi Clinic	Nishi-ku	Fukuoka
Japan	Banno Clinic	Ohta-ku	Tokyo
Japan	Nakaoka Clinic	Osaka
Japan	Department of internal gastro-intestinal medicine Ohshima clinic	Sapporo	Hokkaido
Japan	Hatano Medical Clinic	Setagaya-ku	Tokyo
Japan	Suzuki Circulatory Medical Clinic	Setagaya-ku	Tokyo
Japan	Sakakibara Clinic, Wakaumekai Medical Corporation	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.	52 weeks
Secondary	Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary	Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary	Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary	Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia	Value at each visits minus value at baseline	Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Secondary	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Weeks 4, 12, 24, and 52
Secondary	Percent Change From Baseline in Total Cholesterol (TC) at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Weeks 4, 12, 24, and 52
Secondary	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Weeks 4, 12, 24, and 52
Secondary	Percent Change From Baseline in Triglyceride (TG) at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Week 4, 12, 24, and 52
Secondary	Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit	Value at each visits minus value at baseline	Weeks 4, 12, 24, and 52
Secondary	Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit	Value at each visits minus value at baseline	Weeks 4, 12, 24, and 52
Secondary	Percent Change From Baseline in Apolipoprotein B at Each Visit	"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100	Week 4, 12, 24, and 52

External Links

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