Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131846
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2005-08-17
Brief Title:
Diuretics In the Management of Essential Hypertension DIME Study
Sponsor:
Kyoto University
Organization:
Kyoto University
Study Overview
Official Title:
Effect of Low Dose Thiazide Diuretics on New Onset Type 2 Diabetes in Patients With Essential Hypertension
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of DIME is to evaluate the safety ie new onset of diabetes and other metabolic adverse events efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics The researchers hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives effective in reduction of blood pressure and cheaper than treatment without diuretics Therefore this study is an equivalence trial
Detailed Description:
There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension Diuretics may be more effective in reduction of blood pressure in Japanese patients than Caucasian because of higher salt intake Moreover given a large number of hypertensive population here diuretics may be the most cost-effective antihypertensive agent Japanese physicians however tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes which is deemed to increase cardiovascular risk Although it is unlikely that use of low dose 125 mg of HCTZ or less diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents eg Ca antagonist ACE inhibitor ARB K sparing diuretics other than β-blockers the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in Japanese who are assumed to be diabetes prone based upon thrifty gene hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None