Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
NCT01190007
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- 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
- 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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| 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 |
| |||
| 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 | 159 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||