CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 166 enrolled
Drug / intervention
Study#1: chlorthalidone (CTD), titrated dose +4 moredrug
Likely dose
Chlorthalidone 12.5-25 mg daily (titrated) or 25 mg daily (fixed); Spironolactone 25-75 mg daily (titrated) or 25 mg daily (fixed); Irbesartan 150 mg daily (fixed)AI-extracted
Key inclusion· 1
  • Untreated stage 1 primary hypertension with systolic BP 140-159 mmHg and diastolic BP 90-99 mmHg
Key exclusion· 7
  • Cardiopulmonary disease by history or physical examination
  • Serum creatinine ≥1.5 mg/dL
  • Diabetes mellitus or other systemic illness
  • Left ventricular hypertrophy by echocardiography or ECG

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00353652
NCT00353652Phase 4Completed

Neural Mechanisms of Thiazide-induced Insulin Resistance

University of Texas Southwestern Medical Center·interventional·Posted Jul 19, 2006·Updated Feb 6, 2019

In Brief

A Phase 4 clinical trial evaluating Study#1: chlorthalidone (CTD), titrated dose, Study #1: spironolactone (SP), titrated dose, and 3 other interventions for Hypertension. Completed, enrolled 166 participants across 2 sites.

Detailed Summary

Thiazide medications are often prescribed for individuals with high blood pressure, but research has shown that they may increase an individual's risk of developing diabetes. While it is unknown exactly how thiazide causes this response, it is likely that the nervous system is somehow involved. This study will evaluate the role of the nervous system in sugar metabolism, as well as determine the effect of thiazide and other medications on individuals with high blood pressure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 19, 2006
Enrollment StartJan 1, 2005
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 20.0 years ago

Interventions

Study#1: chlorthalidone (CTD), titrated dosedrug

Participants in study #1 will receive 3 months of chlorthalidone (12.5-25 mg/d) at the dose titrated to achieve 24-h ambulatory BP \< 130/80 mmHg

Study #1: spironolactone (SP), titrated dosedrug

Participants in study #1 will receive 3 months spironolactone (25-75 mg/d), at the dose titrated to achieve 24-h ambulatory BP \< 130/80 mmHg.

Study# 2 chlorthalidone (CTD), fixed dosedrug

Participants in study #2 will receive 3 months of fixed-dose of CTD, at 25 mg/d.

Study# 2 spironolactone (SP), fixed dosedrug

Participants in study #2 will receive 3 months of fixed-dose SP at 25 mg daily.

Study# 2 irbsesartan (IR), fixed dosedrug

Participants in study #2 will receive 3 months of fixed-dose IR at150 mg daily.