Safety, tolerability and efficacy of hypertension treatment with domperidone patients with sleep apnea.

Safety, tolerability and efficacy of nocturnal hypertension treatment with domperidone in the sleep apnea-hypopnea syndrome. Pilot study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000645-23-ES

Enrollment

Registered

2015-03-27

Start date

2015-06-19

Completion date

Unknown

Last updated

2018-11-12

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

Conditions

Nocturnal hypertension in the sleep apnea-hypopnea syndrome. MedDRA version: 17.1 Level: LLT Classification code 10040976 Term: Sleep apnea syndrome System Organ Class: 100000004855 MedDRA version: 17.1 Level: LLT Classification code 10019180 Term: HBP System Organ Class: 100000004866

Interventions

Trade Name: Motilium Pharmaceutical Form: Coated tablet INN or Proposed INN: DOMPERIDONE CAS Number: 57808-66-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: a) Men aged between 18 and 65 years old. b) Apnea hypopnea index (AHI) during sleep greater than 30. c) Nocturnal hypertension (Mean nocturnal systolic blood pressure equal or greater than 120 mmHg). d) Signature of informed consent to participate in the study. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a) Obesity (BMI> 35). b) Previous treatment with CPAP (Continuous Positive Airway Pressure). c) Disabling daytime sleepiness or difficulting patient activity. d) Notorious cardiovascular, renal, hepatic or hematologic comorbidities at the discretion of the investigator would interfere with the study results. e) Antihypertensive drugs intake. f) Any contraindication to domperidone (allergy compound, prolactinoma, gastrointestinal hemorrhage, mechanical obstruction, perforation, mesenteric ischemia) (see ANNEX I: Overview of the drug). g) Intake of anticholinergic drugs, ketoconazole, erythromycin or other potent CYP3A4 inhibitors that prolong the QT interval. h) Written informed consent not obtained.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of treatment with domperidone and to analyze pressure values after administration of domperidone in male patients with sleep apnea-hypopnea syndrome during sleep (SAHS) and nocturnal hypertension.;Secondary Objective: To analyze possible changes in quality of life for male patients with SAHS and nocturnal hypertension evaluating possible differences in clinical questionnaires before and after administration of domperidone.;Primary end point(s): Incidence of adverse events related to study medication, and changes in nocturnal blood pressure (BP): SBP and DBP by ambulatory monitoring of blood pressure..;Timepoint(s) of evaluation of this end point: Adverse reactions will be evaluated along the study (12 weeks). Ambulatory monitoring of blood pressure will be evaluated at the Screening, Week 6 and Week 12.	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of treatment with domperidone and to analyze pressure values after administration of domperidone in male patients with sleep apnea-hypopnea syndrome during sleep (SAHS) and nocturnal hypertension.;Secondary Objective: To analyze possible changes in quality of life for male patients with SAHS and nocturnal hypertension evaluating possible differences in clinical questionnaires before and after administration of domperidone.;Primary end point(s): Incidence of adverse events related to study medication, and changes in nocturnal blood pressure (BP): SBP and DBP by ambulatory monitoring of blood pressure..;Timepoint(s) of evaluation of this end point: Adverse reactions will be evaluated along the study (12 weeks). Ambulatory monitoring of blood pressure will be evaluated at the Screening, Week 6 and Week 12.

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in Epworth Sleepiness Scale and Quebec questionnaire. Changes in the quality of life of patients using EuroQoL-5D.;Timepoint(s) of evaluation of this end point: Day 0 and Week 12.	—

Countries

Spain

Contacts

Public ContactClinical Trials Department

Dynamic Science S.L.

l.plasencia@dynasolutions.com0034914561105

Outcome results

None listed

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