Status:
COMPLETED
Effect of Regular Sildenafil on Blood Pressure and Arterial Function in Hypertension
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
Pfizer
Conditions:
Hypertension
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate if regular treatment with sildenafil reduces blood pressure and improves blood vessel function in patients with hypertension (high blood pressure).
Detailed Description
Inhibitors of phosphodiesterase type 5 (PDE5), such as sildenafil, relax blood vessels. In the penis this facilitates erection and sildenafil has proved a very effective treatment for male erectile dy...
Eligibility Criteria
Inclusion
- Male or female
- Hypertensive (office systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), not taking antihypertensive drugs OR hypertensive controlled (systolic BP \< 160 mmHg or diastolic BP \< 100 mmHg) on 1 antihypertensive agent
- Hypertension confirmed on ambulatory monitoring (average daytime BP ≥145/95 mmHg)
- Patients will also be included if they have 'borderline' hypertension and their calculated 10-year risk of cardiovascular disease is \>20% or they have target organ damage. Borderline hypertension will be defined according to ambulatory BP criteria alone (average awake systolic BP ≥135 and \<145 mmHg or diastolic BP ≥85 and \<95 mmHg).
Exclusion
- History of other major cardiac, respiratory, neurological or renal disease
- Systolic BP consistently \>210 mmHg or diastolic BP consistently \>120 mmHg
- Systolic BP consistently \>180 mmHg or diastolic BP consistently \>110 mmHg in those withdrawn from existing therapy
- Current alcohol abuse
- Diabetes
- Taking vasoactive drugs
- Previous serious drug allergy
- Pregnant
- Participation, within 6 months, in other research studies
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00317421
Start Date
March 1 2004
End Date
November 1 2005
Last Update
April 24 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Pharmacology Unit, University of Edinburgh
Edinburgh, Lothian, United Kingdom, EH4 2XU