EARLY METABOLIC CHANGES WITH THIAZIDE OR BETA BLOCKER THERAPY FOR ESSENTIAL HYPERTENSION (MAIN STUDY). - METABOLIC CHANGES WITH THIAZIDE OR BETA BLOCKER THERAPY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004329-90-GB

Enrollment

Registered

2005-02-15

Start date

2005-02-08

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESSENTIAL HYPERTENSION

Interventions

Product Name: ATENOLOL Product Code: N/A Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Capsule* Route of a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients are hypertensive - aged 18-75yrs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -patients with diabetes -patients who have been previously intolerant to any of the study drugs -patients already on any of the study drugs and unable to change to an alternative

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective : This is a study amendment to an ongoing study to identify whether relatively simple investigations such as the oral glucose tolerance test or changes in fasting glucose and insulin will be able to detect early metabolic changes in patients commencing thiazide & beta-blockers for essential hypertension. We would like to extend the study and investigate whether short term treatment with the alternative diuretic, hydrochlorothiazide, the selective beta blocker nebivolol, and the potassium sparing diuretic amiloride show metabolic changes. The protocol will be the same as previously with additional non invasive hameodynamic measurements. ; Secondary Objective: 1. Do patients show a similar change in glucose tolerance after thiazide, beta-blocker therapy or amiloride therapy? 2. Does the combination of drugs cause a greater reduction in glucose tolerance than expected from the response to each drug taken alone? ;Primary end point(s): Change in 2 hour glucose between any drug/drug combination versus placebo.	—

Measure

Time frame

Main Objective: Main objective : This is a study amendment to an ongoing study to identify whether relatively simple investigations such as the oral glucose tolerance test or changes in fasting glucose and insulin will be able to detect early metabolic changes in patients commencing thiazide & beta-blockers for essential hypertension. We would like to extend the study and investigate whether short term treatment with the alternative diuretic, hydrochlorothiazide, the selective beta blocker nebivolol, and the potassium sparing diuretic amiloride show metabolic changes. The protocol will be the same as previously with additional non invasive hameodynamic measurements. ; Secondary Objective: 1. Do patients show a similar change in glucose tolerance after thiazide, beta-blocker therapy or amiloride therapy? 2. Does the combination of drugs cause a greater reduction in glucose tolerance than expected from the response to each drug taken alone? ;Primary end point(s): Change in 2 hour glucose between any drug/drug combination versus placebo.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026