Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension
Recruitment status was Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension|
- Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two?
- Do patients show a similar change in glucose tolerance after thiazide or beta blocker therapy?
- Does the combination of drugs cause a greater reduction in glucose tolerance than expected from the response to each drug taken alone?
|Study Start Date:||September 2006|
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 study.The 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 2.5-5mg 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, 0.5, 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 110/70mmhg or over 160/110mmHg at any time or if the patient has symptoms e.g. headache or dizziness, the patient will be asked to contact study staff. If the blood pressure remains over 160/110 for two measurements, then another antihypertensive therapy may be commenced, or the patient withdrawn from the study. If blood pressure is < 110/70 mmHg with symptoms then a decision may be made to terminate their participation in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380289
|Contact: Professor MJ Brown, MA MSC MD FRCP||01223 762577 (UK)||firstname.lastname@example.org|
|Contact: Dr A Stears, MBBS BSc MRCP||01223 586865 (UK)||email@example.com|
|Clinical Pharmacology Unit, Box 110, Level 3 ACCI, Addenbrookes Hospital||Recruiting|
|Cambridge, United Kingdom, CB2 2QQ|
|Contact: Mrs M Watts 01223 586865 firstname.lastname@example.org|
|Contact: Dr A Stears, MBBS BSc MRCP 01223 586878 email@example.com|
|Principal Investigator:||Professor MJ Brown, MA MSC MD FRCP||Addenbrookes Hosptal NHS Trust/ University of Cambridge|