The purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile and tolerability of nebivolol plus thiazide-like diuretic versus atenolol plus thiazide-like diuretic.

Condition	Intervention
Hypertension	Drug: Nebivolol / Atenolol

Further Study Details: 

Primary Outcomes: Difference in insulin sensitivity
Secondary Outcomes: Difference in 24 hour blood pressure; Difference in cholesterol; Difference in HbA1c; Difference in body weight; Difference in FEV1; Difference in wellbeing; Difference in cerebral blood flow
Expected Total Enrollment:  50

Retrospective studies of treated hypertensive cohorts have strongly implicated beta blocker therapy as increasing the risk of developing new-onset diabetes. This has led to the latest British Hypertension Society guidelines advising caution when using beta blockers particularly in combination with thiazide-like diuretics. However the National Institute of Clinical Excellence recommends beta-blocker + thiazide combinations as the treatment of choice in patients who are not at increased risk of developing diabetes. Nebivolol is a newer class of beta blocker. Some studies in diabetic hypertensive patients have suggested that nebivolol does not impair insulin sensitivity. The aim of this study is to compare the effect on insulin sensitivity of nebivolol versus atenolol, both in combination with a thiazide-like diuretic, in a group of non-diabetic hypertensive patients.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female of any age
• blood pressure that meets any of the three following criteria:
• [1] sbp <= 160 and dbp <= 90 on one antihypertensive drug OR
• [2] sbp <= 140 and dbp <= 85 on two antihypertensive drugs OR
• [3] sbp 140-170 and dbp 90-100 on no antihypertensive drugs

Exclusion Criteria:

• Compelling indication for treatment with a beta blocker
• Contraindication to, or previous history of, major intolerance to treatment with a beta blocker or thiazide-like diuretic.
• Any condition that will interfere with the treatment or the patients ability to complete the study

Please refer to this study by ClinicalTrials.gov identifier  NCT00125853

Sarah L Wilson, BN MSc PhD      020 7594 3423 

United Kingdom, London
      Imperial College London, Paddington,  London,  W2 1PG,  United Kingdom

Study chairs or principal investigators

Neil R Poulter,  Principal Investigator,  Imperial College London   

Study ID Numbers:  NPSW02
Last Updated:  August 1, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00125853
Health Authority: United Kingdom: Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-02