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

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NCT01190007

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Study Location
Healthcare Corporation MEDOC Medical Dock&Clinic
Nagoya, Aichi, , Japan
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension, Hypercholesterolemia, Angina Pectoris
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Hypertension, Hypercholesterolemia, Angina PectorisOpen Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
NCT01190007
  1. Nagoya, Aichi
  2. Dazaifu, Fukuoka
  3. Kitakyushu, Fukuoka
  4. Nishi-ku, Fukuoka
  5. Sapporo, Hokkaido
  6. Amagasaki, Hyogo
  7. Kobe, Hyogo
  8. Kobe, Hyogo
  9. Kawasaki, Kanagawa
  10. Yokohama, Kanagawa
  11. Fujimi, Saitama
  12. Kawaguchi, Saitama
  13. Adachi-ku, Tokyo
  14. Arakawa-ku, Tokyo
  15. Koto-ku, Tokyo
  16. Ohta-ku, Tokyo
  17. Setagaya-ku, Tokyo
  18. Setagaya-ku, Tokyo
  19. Fukuoka,
  20. Osaka,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Hypercholesterolemia
  • Angina Pectoris
Intervention  ICMJE Drug: Caduet
One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks
Study Arms  ICMJE Experimental: Caduet
Intervention: Drug: Caduet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2012)		159
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2010)		150
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01190007
Other Study ID Numbers  ICMJE A3841064
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2012

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