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Investigation of combined phosphodiesterase 5 inhibitor and isosorbide mononitrate for the treatment ofresistant hypertension - Sildenafil and isosorbide mononitrate in resistant hypertensio

Phase 1
Conditions
Hypertension
Registration Number
EUCTR2005-001004-39-GB
Lead Sponsor
niversity of Edinburgh
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

?Essential hypertension
?Office BP >140/85 despite treatment with 3 or more antihypertensive agents
?Resistance to treatment proven by directly observed therapy

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

?Identifiable underlying cause for hypertension (e.g. Conn’s or Cushing’s syndromes, renal artery stenosis, phaeochromocytoma, coarctation of the aorta)
?Clinically evident coronary artery or cerebrovascular disease
?Taking regular organic nitrates or nicorandil
?Significant renal or liver impairment
?Pregnant
?Current alcohol or drug abuse
?Previous serious drug allergy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To characterise the effect on blood pressure of a combination of single doses of sildenafil and isosorbide mononitrate in patients with resistant hypertension. ;Secondary Objective: ;Primary end point(s): Effect on blood pressure of the drug combination
Secondary Outcome Measures
NameTimeMethod
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