Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174330
First received: September 9, 2005
Last updated: February 20, 2007
Last verified: February 2007
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Purpose
To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Hyperlipidemia |
Drug: atorvastatin Drug: amlodipine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Randomized, Open-Label Study To Evaluate Efficacy And Safety Of Dual Therapy With Atorvastatin Plus Amlodipine When Compared Amlodipine Therapy Alone In The Treatment Of Subjects With Concurrent Hyperlipidemia And Hypertension. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To evaluate efficacy of the dual therapy of atorvastatin 10mg or 20mg + amlodipine 5mg or 10mg vs. amlodipine 5mg or 10mg alone
Secondary Outcome Measures:
- To provide comparative evaluation of the safety profile of the dual therapy with atorvastatin + amlodipine versus amlodipine alone.
| Estimated Enrollment: | 330 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | February 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with a diagnosis of both hyperlipidemia and hypertension.
Exclusion Criteria:
- Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus.
- Subjects with other atherosclerotic disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174330
Locations
| China, Beijing | |
| Pfizer Investigational Site | |
| Beijing, Beijing, China, 100044 | |
| China, Guangdong | |
| Pfizer Investigational Site | |
| Guangzhou, Guangdong, China, 510100 | |
| Pfizer Investigational Site | |
| Guangzhou, Guangdong, China, 510515 | |
| Pfizer Investigational Site | |
| Guangzhou, Guangdong, China, 510080 | |
| China, Jiangsu | |
| Pfizer Investigational Site | |
| Nanjing, Jiangsu, China, 210029 | |
| China, Liaoning | |
| Pfizer Investigational Site | |
| Shen Yang, Liaoning, China, 110016 | |
| China, Shanghai | |
| Pfizer Investigational Site | |
| Shanghai, Shanghai, China, 200032 | |
| China, Zhejiang | |
| Pfizer Investigational Site | |
| Hangzhou, Zhejiang, China, 310016 | |
| China | |
| Pfizer Investigational Site | |
| Beijing, China, 100029 | |
| Pfizer Investigational Site | |
| Beijing, China, 100083 | |
| Pfizer Investigational Site | |
| Beijing, China | |
| Pfizer Investigational Site | |
| Shanghai, China, 200233 | |
| Pfizer Investigational Site | |
| Shanghai, China, 200003 | |
| Pfizer Investigational Site | |
| Shanghai, China, 200025 | |
| Pfizer Investigational Site | |
| Tianjin, China, 300211 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00174330 History of Changes |
| Other Study ID Numbers: | A3841026 |
| Study First Received: | September 9, 2005 |
| Last Updated: | February 20, 2007 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hyperlipidemias Hypertension Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Vascular Diseases Cardiovascular Diseases Amlodipine Amlodipine, atorvastatin drug combination Atorvastatin Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 16, 2013