Effect of Regular Sildenafil on Blood Pressure and Arterial Function in Hypertension

NCT00317421 | Completed Phase 2

• 1 other identifier: JO-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Keywords

Phosphodiesterase 5; Sildenafil; Hypertension; Blood pressure; Arterial stiffness; Endothelial function

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Sildenafil citrate DRUG

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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110 mmHg in those withdrawn from existing therapy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

Sponsors & Collaborators

• University of Edinburgh: lead
• Pfizer: collaborator

Study Sites (1)

Clinical Pharmacology Unit, University of Edinburgh

Edinburgh, Lothian, EH4 2XU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 10078541 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• James J Oliver, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 24, 2006
• Study Start: March 1, 2004
• Study Completion: November 1, 2005
• Last Updated: April 24, 2006

Record last verified: 2004-02

Locations

GB (1)