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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 9,306 participants.

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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.

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

FieldValue
Enrollment Target 9,306 participants
Start Date 2002-01
Est. Completion 2009-10
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00097786

The ClinicalTrials.gov registry entry for NCT00097786 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 9,306 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Valsartan 160 mg + nateglinide 60 mg is the first listed.

NCT00097786 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.