| September 13, 2007 |
| April 28, 2009 |
| September 2007 |
| April 2008 (final data collection date for primary outcome measure) |
- Change in Systolic Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Percent Change in Low Density Lipoprotein-Cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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| The change in SBP and the percent change in LDL-C from baseline at Week 8 in the treatment period |
| Complete list of historical versions of study NCT00530946 on ClinicalTrials.gov Archive Site |
- Change in Systolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
- Change in Diastolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
- Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
- Percent Change in Total Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
- Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
- Percent Change in Triglycerides From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
- Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
- Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
- Change in Apolipoprotein B From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
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- 1.The changes in the following efficacy endpoints from baseline to each visit: SBP (except that at Week 8), DBP, LDL-C (except that at Week 8), TC, HDL-C, TG, LDL-C/HDL-C ratio, TC/HDL-C ratio and ApolipoproteinB.
- 2. Safety endpoints (Adverse events, laboratory tests, 12-lead ECG, pulse rate)
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| A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin |
| A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia |
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period |
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| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
- Hypertension
- Hypercholesterolemia
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- Drug: Amlodipine 2.5mg/Atorvastatin 5mg
- Drug: Amlodipine 2.5mg/Atorvastatin 10mg
- Drug: Amlodipine 5mg/Atorvastatin 5mg
- Drug: Amlodipine 5mg/Atorvastatin 10mg
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| |
| |
| Completed |
| 165 |
| April 2008 |
| April 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
- The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
- LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).
Exclusion Criteria:
- Subjects who had experienced the following coronary artery disease within the past 3 months.
- Myocardial infarction
- Receiving PCI(percutaneous coronary intervention)or CABG (coronary artery bypass grafting)
- Any clinically meaningful valvular disease
- Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
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| Both |
| 20 Years to 79 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| NCT00530946 |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| A3841058 |
| Pfizer |
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer |
| March 2009 |