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Sponsors and Collaborators: |
Imperial College London British Heart Foundation Institut De Recherche International Servier |
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Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00122811 |
The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Indapamide SR 1.5mg; Perindopril 2-4mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Hypertension in the Very Elderly Trial (HYVET) |
Estimated Enrollment: | 4000 |
Study Start Date: | November 2000 |
Estimated Study Completion Date: | October 2008 |
The benefit to risk ratio of treating hypertensives aged 80 or older has not been established. It has been suggested that at this age for each stroke prevented there is one non-stroke death. HYVET is designed to help clarify this.
HYVET is a randomised, double-blind, placebo-controlled trial in hypertensive subjects aged 80 or older. Active treatment consists of indapamide 1.5mg SR with the addition of perindopril 2mg - 4mg to reach a target blood pressure (BP) of <150/80 mmHg. Entry criteria include a systolic blood pressure of 160-199 mmHg. Patients with isolated systolic hypertension (ISH) have been recruited since August 2003.
Ages Eligible for Study: | 80 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
University Hospital St. Anna | |
Sofia, Bulgaria, 1784 Sofia | |
Department of Internal Medicine, Clinic of Rheumatology | |
Plovdiv, Bulgaria, 4002 Plovdiv | |
China | |
Dept of Hypertension Fu Wai Hospital | |
Beijing, China, 100037, China | |
Finland | |
Kontinkangas Hospital Research | |
Oulu, Finland, 90015 Oulu | |
Romania | |
UMF Cluj, Clinica Medicala III | |
Cluj, Romania, 3400, Cluj | |
Russian Federation | |
State Scientific Research Institute of Internal Medicine, Russian Academy of Medical Sciences Siberian Department | |
Novosibirsk, Russian Federation | |
United Kingdom | |
Imperial College London | |
London, United Kingdom, W12 0NN |
Principal Investigator: | Christopher J Bulpitt, MD, FRCP | Imperial College London |
Study ID Numbers: | RG/97010 |
Study First Received: | July 13, 2005 |
Last Updated: | August 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00122811 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Aged Hypertension Stroke |
Perindopril Indapamide Cerebral Infarction |
Stroke Vascular Diseases Hypertension |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |