Pheochromocytoma RandomisEd Study Comparing adRenoreceptor Inhibiting agents for Preoperative Treatment - PRESCRIPT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022417-25-NL

Enrollment

134

Registered

2010-12-02

Start date

2011-04-18

Completion date

Unknown

Last updated

2018-05-07

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

Conditions

Perioperative hemodynamic control in patients undergoing resection of a pheochromocytoma MedDRA version: 12.1 Level: LLT Classification code 10034876 Term: Pheochromocytoma

Interventions

Trade Name: Dibenzyran Product Name: phenoxybenzamine Product Code: not applicable Pharmaceutical Form: Capsule* INN or Proposed INN: PHENOXYBENZAMINE HYDROCHLORIDE CAS Number: 63923 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: o age > 18 years o diagnosis of benign PCC (adrenal or extra-adrenal, sporadic or hereditary) o planned for surgical removal of the PCC 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: o age < 18 years o malignant PCC o severe hemodynamic instability before surgery necessitating admission to intensive care unit o pregnancy o incapability to adhere to the study protocol

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The number of patients demonstrating more than three intraoperative episodes of 5 minutes with blood pressure outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin.;Secondary Objective: - need for additional antihypertensive agents - adverse effects of study medication - distribution frequency of germline mutations associated with PCC - length of postoperative stay at intensive care unit - length of hospital stay - postoperative hypoglycaemia: frequency and severity (in mmol/L) - perioperative mortality (i.e. death from any cause occurring during period from first administration of study medication until 30 days after surgery) - perioperative cardiovascular morbidity, i.e. cardiovascular events occurring during period from first administration of study medication until 30 days after surgery. Cardiovascular events are: myocardial infarction, cardiac arrhythmia requiring medical intervention, heart failure, cerebrovascular ischemia, cerebrovascular haemorrhage - composite endpoint of perioperative mortality and perioperative cardiovascular morbidity ;Main Objective: The primary objective of this randomised controlled trial is to determine which of the two commonly used alfa-adrenoceptor antagonists – phenoxybenzamine and doxazosin – provides the best intraoperative blood pressure control in patients with a pheochromocytoma (PCC).	—

Measure

Time frame

Primary end point(s): The number of patients demonstrating more than three intraoperative episodes of 5 minutes with blood pressure outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin.;Secondary Objective: - need for additional antihypertensive agents - adverse effects of study medication - distribution frequency of germline mutations associated with PCC - length of postoperative stay at intensive care unit - length of hospital stay - postoperative hypoglycaemia: frequency and severity (in mmol/L) - perioperative mortality (i.e. death from any cause occurring during period from first administration of study medication until 30 days after surgery) - perioperative cardiovascular morbidity, i.e. cardiovascular events occurring during period from first administration of study medication until 30 days after surgery. Cardiovascular events are: myocardial infarction, cardiac arrhythmia requiring medical intervention, heart failure, cerebrovascular ischemia, cerebrovascular haemorrhage - composite endpoint of perioperative mortality and perioperative cardiovascular morbidity ;Main Objective: The primary objective of this randomised controlled trial is to determine which of the two commonly used alfa-adrenoceptor antagonists – phenoxybenzamine and doxazosin – provides the best intraoperative blood pressure control in patients with a pheochromocytoma (PCC).

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Countries

Netherlands

Outcome results

None listed

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