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

• ClinicalTrials.gov Identifier: NCT01190007
• Recruitment Status: Completed
• First Posted: August 27, 2010
• Results First Posted: December 3, 2012
• Last Update Posted: January 28, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Hypercholesterolemia; Angina Pectoris	Drug: Caduet	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 159 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: August 2010
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Caduet	Drug: Caduet; One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 52 weeks ]
   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.

Secondary Outcome Measures :

1. Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
   Value at each visits minus value at baseline
2. Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
   Value at each visits minus value at baseline
3. Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
   Value at each visits minus value at baseline
4. Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia [ Time Frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
   Value at each visits minus value at baseline
5. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit [ Time Frame: Weeks 4, 12, 24, and 52 ]
   "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
6. Percent Change From Baseline in Total Cholesterol (TC) at Each Visit [ Time Frame: Weeks 4, 12, 24, and 52 ]
   "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
7. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit [ Time Frame: Weeks 4, 12, 24, and 52 ]
   "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
8. Percent Change From Baseline in Triglyceride (TG) at Each Visit [ Time Frame: Week 4, 12, 24, and 52 ]
   "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
9. Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit [ Time Frame: Weeks 4, 12, 24, and 52 ]
   Value at each visits minus value at baseline
10. Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit [ Time Frame: Weeks 4, 12, 24, and 52 ]
    Value at each visits minus value at baseline
11. Percent Change From Baseline in Apolipoprotein B at Each Visit [ Time Frame: Week 4, 12, 24, and 52 ]
    "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Yano Cardiovascular Clinic

Fukuoka, Japan

Nakaoka Clinic

Osaka, Japan

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01190007
• Other Study ID Numbers: A3841064
• First Posted: August 27, 2010
• Results First Posted: December 3, 2012
• Last Update Posted: January 28, 2021
• Last Verified: January 2021

Additional relevant MeSH terms:

Hypertension; Angina Pectoris; Hypercholesterolemia; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Chest Pain; Pain; Neurologic Manifestations; Amlodipine, atorvastatin drug combination; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors