---
title: A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)
nct_id: NCT00110435
overall_status: COMPLETED
phase: PHASE3
sponsor: Organon and Co
study_type: INTERVENTIONAL
primary_condition: Type 2 Diabetes Mellitus
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00110435.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00110435"
ct_last_update_post_date: 2024-08-15
last_seen_at: "2026-05-12T06:00:19.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)

**Official Title:** A Multicenter, Randomized, Double-blind, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia

**NCT ID:** [NCT00110435](https://clinicaltrials.gov/study/NCT00110435)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1229
- **Lead Sponsor:** Organon and Co
- **Conditions:** Type 2 Diabetes Mellitus, Hypercholesterolemia
- **Start Date:** 2005-05
- **Completion Date:** 2005-12
- **CT.gov Last Update:** 2024-08-15

## Brief Summary

The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 79 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Type 2 Diabetes Mellitus that is poorly controlled
```

## Interventions

- **MK0653A, ezetimibe (+) simvastatin** (DRUG)
- **Duration of Treatment: 4 wk placebo run in then 6 wk active** (DRUG)
- **Comparator: atorvastatin** (DRUG)

## Primary Outcomes

- **Percent reduction in LDL-C from baseline after 6 weeks of treatment**

## Secondary Outcomes

- **Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment**

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00110435.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00110435*  
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