Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01190007
First received: August 5, 2010
Last updated: December 19, 2012
Last verified: December 2012
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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
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 Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
Amlodipine, atorvastatin drug combination Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses Antihypertensive Agents Cardiovascular Agents Calcium Channel Blockers Membrane Transport Modulators |
ClinicalTrials.gov processed this record on May 21, 2013