Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380289
Status:
UNKNOWN
Last Update Posted:
2006-09-25
First Post:
2006-09-22
Brief Title:
Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension
Sponsor:
University of Cambridge
Organization:
University of Cambridge
Study Overview
Official Title:
Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
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:
Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two
Detailed Description:
We will be comparing the two most commonly used drugs to treat hypertension atenolol and bendrofluazide in patients for whom the drugs and the doses to be used are licenced
We propose an initial open label pilot study of 10-12 patients to confirm final doses to be tested the duration of therapy for optimum timing of the OGTT and tolerability of doses selected The pilot study will also be used to confirm sample size calculations for the main studyThe protocol for the pilot study will be identical to the main study but there will not be a placebo phase and the treatment will not be blinded
The main study will be double-blind placebo controlled cross-over study of approximately 66 patients in which each patient receives in random order 4 weeks treatment with either Bendrofluazide 5-10mg daily Atenolol 50-100mg daily or combination of Bendrofluazide 25-5mg and Atenolol 25-50mg daily There will be a forced titration from the lower to the higher dose stated half way through each dosing period There will be a 1 month placebo wash-out between each dosing period
At 0 2 and 4 weeks of each treatment phase patients will attend the Clinical Investigation Ward CIW fasting for performance of an oral glucose tolerance test OGTT Blood will be drawn from an intravenous cannula for the measurements of glucose and insulin at 0 05 1 and 2 hours
Blood pressure will be measured at each study visit using an Omron machine The patients will also be given a blood pressure machine to take home and will be asked to measure and record their blood pressure at least twice per week If their blood pressure is under 11070mmhg or over 160110mmHg at any time or if the patient has symptoms eg headache or dizziness the patient will be asked to contact study staff If the blood pressure remains over 160110 for two measurements then another antihypertensive therapy may be commenced or the patient withdrawn from the study If blood pressure is 11070 mmHg with symptoms then a decision may be made to terminate their participation in the study
We propose an initial open label pilot study of 10-12 patients to confirm final doses to be tested the duration of therapy for optimum timing of the OGTT and tolerability of doses selected The pilot study will also be used to confirm sample size calculations for the main studyThe protocol for the pilot study will be identical to the main study but there will not be a placebo phase and the treatment will not be blinded
The main study will be double-blind placebo controlled cross-over study of approximately 66 patients in which each patient receives in random order 4 weeks treatment with either Bendrofluazide 5-10mg daily Atenolol 50-100mg daily or combination of Bendrofluazide 25-5mg and Atenolol 25-50mg daily There will be a forced titration from the lower to the higher dose stated half way through each dosing period There will be a 1 month placebo wash-out between each dosing period
At 0 2 and 4 weeks of each treatment phase patients will attend the Clinical Investigation Ward CIW fasting for performance of an oral glucose tolerance test OGTT Blood will be drawn from an intravenous cannula for the measurements of glucose and insulin at 0 05 1 and 2 hours
Blood pressure will be measured at each study visit using an Omron machine The patients will also be given a blood pressure machine to take home and will be asked to measure and record their blood pressure at least twice per week If their blood pressure is under 11070mmhg or over 160110mmHg at any time or if the patient has symptoms eg headache or dizziness the patient will be asked to contact study staff If the blood pressure remains over 160110 for two measurements then another antihypertensive therapy may be commenced or the patient withdrawn from the study If blood pressure is 11070 mmHg with symptoms then a decision may be made to terminate their participation in the study
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