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NCT00097786 · ClinicalTrials.gov registry record · Phase 3
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 9,306
- Enrollment target
NCT00097786: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00097786 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 9,306 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1107% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00097786, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 9,306 participants
- Enrollment target
Study Summary
This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.
Primary Outcome
Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.
Interventions
- DRUG Valsartan 160 mg + nateglinide 60 mg
- DRUG Valsartan 160 mg + nateglinide placebo
- DRUG Nateglinide 60 mg + valsartan placebo
- DRUG Valsartan placebo + nateglinide placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,306 participants |
| Start Date | 2002-01 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00097786 record still lists
NCT00097786 is an interventional study that assigns participants to a tested intervention. Its 9,306 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1107% higher).
The record links to 0 conditions, and to 4 interventions - of which Valsartan 160 mg + nateglinide 60 mg is the first listed.
NCT00097786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00097786 about?
NCT00097786 is a clinical study titled "Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications". This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are co...
What is the current status of trial NCT00097786?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 9,306 participants. The study started on 2002-01. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00097786?
The interventions under investigation include: Valsartan 160 mg + nateglinide 60 mg (DRUG), Valsartan 160 mg + nateglinide placebo (DRUG), Nateglinide 60 mg + valsartan placebo (DRUG), Valsartan placebo + nateglinide placebo (DRUG).
Who is sponsoring clinical trial NCT00097786?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00097786's enrollment target sits among peer trials
9,306 31st of 2000 higher than 1,970 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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