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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
History of Changes

August 5, 2010
December 19, 2012
August 2010
February 2012   (final data collection date for primary outcome measure)
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.
Assessment of long-term safety profile based on AEs, clinical laboratory test, ECG, pulse rate and angina condition [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01190007 on ClinicalTrials.gov Archive Site
  • 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
  • Change from baseline in trough systolic blood pressure (SBP) at each visit [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
  • Change from baseline in trough diastolic blood pressure (DBP) at each visit [ Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in LDL-C at each visit [ Time Frame: Baseline, Week 4, 12, 24, 52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in TC at each visit [ Time Frame: Baseline, Week 4, 12, 24, 52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in HDL-C at each visit [ Time Frame: Baseline, Week 4, 12, 24, 52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in TG at each visit [ Time Frame: Baseline, Week 4, 12, 24, 52 ] [ Designated as safety issue: No ]
  • Change from baseline in ratio of LDL-C to HDL-C at each visit [ Time Frame: Baseline, Week 4, 12, 24, 52 ] [ Designated as safety issue: No ]
  • Change from baseline in ratio of TC to HDL-C at each visit [ Time Frame: Baseline, Week 4, 12, 24, 52 ] [ Designated as safety issue: No ]
  • Percent change from baseline in apolipoprotein B at each visit [ Time Frame: Baseline, Week 4, 12, 24, 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
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

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Hypercholesterolemia
  • Angina Pectoris
Drug: Caduet
One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks
Experimental: Caduet
Intervention: Drug: Caduet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01190007
A3841064
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP