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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001004-39-GB

Enrollment

Registered

2005-05-06

Start date

2005-07-05

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Trade Name: Viagra Product Name: Viagra Pharmaceutical Form: Tablet INN or Proposed INN: Sildenafil citrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Phar

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026