HypertensionPhase 2NCT00317421
Effect of Regular Sildenafil on Blood Pressure and Arterial Function in Hypertension
A Phase 2 study testing Sildenafil citrate in people with Hypertension, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Sildenafil citrate
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2004to Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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110 mmHg in those withdrawn from existing therapy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
Show all 9Show fewer
- Previous serious drug allergy
- Pregnant
- Participation, within 6 months, in other research studies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Pharmacology Unit, University of Edinburgh
Edinburgh, Lothian, EH4 2XU
About this study
Official title: Effects of Regular Treatment With Sildenafil on Blood Pressure and Endothelial Function in Untreated Hypertensives
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).
Read the 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 dysfunction.
To date, most work on the effects of sildenafil on blood pressure have mainly been investigated in single dose studies. These have shown that sildenafil causes a modest reduction in blood pressure, even when taken with other blood pressure-lowering drugs, providing reassurance on safety when taken as a single dose for erectile dysfunction. However, these studies do not offer any insight into the potential of PDE5 inhibition in the long-term treatment of hypertension. We will address this question by investigating the effects of regular administration of sildenafil on blood pressure. It may also be postulated that, because of its mechanism of action, sildenafil will also improve the function of the endothelium, the single layer of cells that lines all blood vessels. Therefore, the effect of regular sildenafil on endothelial function in hypertension will also be investigated in the study.
The study will be performed in a randomised, placebo-controlled, double blind, 2-way crossover manner. Sildenafil and matched placebo will each will taken three times daily for 2 weeks, with a washout of at least 6 days between treatments. Measurements will be made acutely (before and 1 hour after oral sildenafil) of heart rate, blood pressure, pulse wave analysis (a measure of wave reflection in arteries), pulse wave velocity (a measure of arterial stiffness) and flow-mediated dilatation (a measure of endothelial function). These measurements will be repeated 2 weeks later (again just before and 1 hour after oral sildenafil). In addition, ambulatory blood pressure will be recorded after 2 weeks of treatment (baseline ambulatory BP will be taken as the recording made at diagnosis).
- Conditions
- Hypertension
- Being tested
- Sildenafil citrate
- Keywords
- Phosphodiesterase 5, Sildenafil, Hypertension, Blood pressure, Arterial stiffness, Endothelial function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil citrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Change in flow-mediated dilatation
Change in central augmentation index (derived from pulse wave analysis)
Change in carotid-femoral pulse wave velocity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2006 (estimated)
- Study startMar 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- James J Oliver, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317421
- Sponsor's protocol ID
- JO-02
- Status last verified
- Feb 2004
- First submitted
- 20 Apr 2006
- Last updated
- 24 Apr 2006
- Results posted
- No
Publications
Zusman RM, Morales A, Glasser DB, Osterloh IH. Overall cardiovascular profile of sildenafil citrate. Am J Cardiol. 1999 Mar 4;83(5A):35C-44C. doi: 10.1016/s0002-9149(99)00046-6.
PubMed 10078541
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regular Treatment With Sildenafil on Blood Pressure and Endothelial Function in Untreated Hypertensives
- ClinicalTrials.gov ID
- NCT00317421
- Acronym / sponsor ID
- JO-02
- Conditions
- Hypertension
- Keywords
- Phosphodiesterase 5, Sildenafil, Hypertension, Blood pressure, Arterial stiffness, Endothelial function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2004
- Study completion
- Nov 2005
- First posted
- 24 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 dysfunction.
To date, most work on the effects of sildenafil on blood pressure have mainly been investigated in single dose studies. These have shown that sildenafil causes a modest reduction in blood pressure, even when taken with other blood pressure-lowering drugs, providing reassurance on safety when taken as a single dose for erectile dysfunction. However, these studies do not offer any insight into the potential of PDE5 inhibition in the long-term treatment of hypertension. We will address this question by investigating the effects of regular administration of sildenafil on blood pressure. It may also be postulated that, because of its mechanism of action, sildenafil will also improve the function of the endothelium, the single layer of cells that lines all blood vessels. Therefore, the effect of regular sildenafil on endothelial function in hypertension will also be investigated in the study.
The study will be performed in a randomised, placebo-controlled, double blind, 2-way crossover manner. Sildenafil and matched placebo will each will taken three times daily for 2 weeks, with a washout of at least 6 days between treatments. Measurements will be made acutely (before and 1 hour after oral sildenafil) of heart rate, blood pressure, pulse wave analysis (a measure of wave reflection in arteries), pulse wave velocity (a measure of arterial stiffness) and flow-mediated dilatation (a measure of endothelial function). These measurements will be repeated 2 weeks later (again just before and 1 hour after oral sildenafil). In addition, ambulatory blood pressure will be recorded after 2 weeks of treatment (baseline ambulatory BP will be taken as the recording made at diagnosis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil citrate | Drug | – |
Primary outcome
Change in blood pressure
Change in flow-mediated dilatation
Change in central augmentation index (derived from pulse wave analysis)
Change in carotid-femoral pulse wave velocity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2006.
- Background: PubMed 10078541Zusman RM, Morales A, Glasser DB, Osterloh IH. Overall cardiovascular profile of sildenafil citrate. Am J Cardiol. 1999 Mar 4;83(5A):35C-44C. doi: 10.1016/s0002-9149(99)00046-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J Oliver, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil citrate in people with Hypertension, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00317421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2006.