Effects of an ARB on Microcirculation in Essential Hypertensio

• Conditions: Essential hypertension; MedDRA version: 14.1Level: LLTClassification code 10004254Term: Benign essential hypertensionSystem Organ Class: 10047065 - Vascular disorders

• Registration Number: EUCTR2008-005432-32-GB
• Lead Sponsor: St. George's University of London (SGUL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-16
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Patients with uncomplicated mild-to-moderate essential hypertension (sitting diastolic BP = 90 - <110 mmHg and/or systolic BP =140–<180 mmHg) who have not been previously treated for their high blood pressure. Patients age 18-75 years old.
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

1. Malignant or accelerated hypertension.
2. Serum creatinine >180 µmol/L
3. Ischaemic heart disease
4. Cerebrovascular disease
5. Impaired liver functions
6. Diabetes mellitus
7. Pregnancy or risk of pregnancy, or lactation
8. History of alcoholism, drug abuse or other problems that are likely to invalidate the informed consent.
9. Dark-skinned individuals (capillary microscopy can’t be performed).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The increase in maximal skin capillary density at the end of 8 weeks treatment.;Main Objective: To evaluate the effects of controlling blood pressure with candesartan 8-16 mg od versus amlodipine 5-10 mg od on microvascular capillary rarefaction in patients with mild-to-moderate essential hypertension.;Secondary Objective: To evaluate the effects of controlling blood pressure with candesartan 8-16 mg od versus amlodipine 5-10 mg od on pulse wave velocity, aortic augmentation index, and microalbuminuria.