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NCT00412113 · ClinicalTrials.gov registry record · Phase 4
A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 245
- Enrollment target
NCT00412113: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00412113 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 245 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00412113, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 245 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.
Primary Outcome
Number of subjects reaching dual goal of systolic blood pressure \<140 millimeters of mercury (mmHg) and diastolic blood pressue of \<90 mmHg and low density lipoprotein-cholesterol(LDL-C) \<100 milligrams per deciliter(mg/dL)
Interventions
- DRUG Amlodipine besylate
- DRUG Amlodipine besylate/atorvastatin calcium single pill combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
What the finished NCT00412113 record still lists
NCT00412113 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Amlodipine besylate is the first listed.
NCT00412113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00412113 about?
NCT00412113 is a clinical study titled "A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk". The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with...
What is the current status of trial NCT00412113?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 245 participants. The study started on 2007-01. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00412113?
The interventions under investigation include: Amlodipine besylate (DRUG), Amlodipine besylate/atorvastatin calcium single pill combination (DRUG).
Who is sponsoring clinical trial NCT00412113?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00412113's enrollment target sits among peer trials
245 357th of 2000 higher than 1,644 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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