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OpenTrials
Completed

NCT Number: NCT01190007

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

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.

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Key information

Conditions

Hypertension Angina Pectoris Cardiovascular Diseases Chest Pain Dyslipidemias Heart Diseases Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caduet

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2010
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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