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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01190007
First received: August 5, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Hypertension
Hypercholesterolemia
Angina Pectoris
Drug: Caduet
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Value at each visits minus value at baseline

  • 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 ] [ Designated as safety issue: No ]
    Value at each visits minus value at baseline

  • 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 ] [ Designated as safety issue: No ]
    Value at each visits minus value at baseline

  • 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 ] [ Designated as safety issue: No ]
    Value at each visits minus value at baseline

  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit [ Time Frame: Weeks 4, 12, 24, and 52 ] [ Designated as safety issue: No ]
    "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

  • Percent Change From Baseline in Total Cholesterol (TC) at Each Visit [ Time Frame: Weeks 4, 12, 24, and 52 ] [ Designated as safety issue: No ]
    "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

  • Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit [ Time Frame: Weeks 4, 12, 24, and 52 ] [ Designated as safety issue: No ]
    "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

  • Percent Change From Baseline in Triglyceride (TG) at Each Visit [ Time Frame: Week 4, 12, 24, and 52 ] [ Designated as safety issue: No ]
    "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100

  • 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 ] [ Designated as safety issue: No ]
    Value at each visits minus value at baseline

  • 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 ] [ Designated as safety issue: No ]
    Value at each visits minus value at baseline

  • Percent Change From Baseline in Apolipoprotein B at Each Visit [ Time Frame: Week 4, 12, 24, and 52 ] [ Designated as safety issue: No ]
    "Value at each visits minus value at baseline" divided by value at baseline multiplied by 100


Enrollment: 159
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caduet Drug: Caduet
One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190007

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
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01190007     History of Changes
Other Study ID Numbers: A3841064
Study First Received: August 5, 2010
Results First Received: November 1, 2012
Last Updated: December 19, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Angina Pectoris
Hypercholesterolemia
Hypertension
Cardiovascular Diseases
Chest Pain
Dyslipidemias
Heart Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Amlodipine, atorvastatin drug combination
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Calcium Channel Blockers
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014