Treatment of hypertension at nigth in type 1 diabetes patients with no 24 hour variation of thier bloodpressure.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002136-90-DK

Enrollment

Registered

2012-06-18

Start date

2012-06-19

Completion date

Unknown

Last updated

2021-08-10

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

Conditions

Patients with type 1 diabetes with autonomic neuropathy or no 24h variation in bloodpressure.

Interventions

Trade Name: Enalaprilmaleat Product Name: Enacodan Pharmaceutical Form: Tablet INN or Proposed INN: Enacodan CAS Number: 76095-16-4 Other descriptive name: ENALAPRIL MALEATE Concentration unit: mg mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 1 diabetes Age 18-65 years HbA1C =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Albinuria Se-createnine>120 mikromol/l Sleep apnea Workload at nigth A history of renal arthery stenosis or renal disease/nephrectimy Primor angiooedema or serius sideeffects during treatment with ACE-inhibitors or ANG11 - antagonist Everyday use of NSAID up to 4 weeks before inclusion Bad compliance Cancer or any other significant disease that could effect the trial Women planning a pregnancy, are pregnant or nursing Women who do not use contraception (contraceptive pill or IUD(Intra uterine device)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Noctuenal bloodpresure reduction by antihypertensive treatment at nigth comperred with drug administration in the morning;Timepoint(s) of evaluation of this end point: 24 weeks;Main Objective: Treatment of hypertension at nigth in patients with type 1 diabetes - with no 24h variation in bloodpressure implies a more suitable bloodpressure management, compared with conventional treatment (administration of drugs in the morning);Secondary Objective: Nocturnal bloodpressure treatment has a measurable effect on cardiovasculare risk factors, including left ventricular mass.	—

Measure

Time frame

Primary end point(s): Noctuenal bloodpresure reduction by antihypertensive treatment at nigth comperred with drug administration in the morning;Timepoint(s) of evaluation of this end point: 24 weeks;Main Objective: Treatment of hypertension at nigth in patients with type 1 diabetes - with no 24h variation in bloodpressure implies a more suitable bloodpressure management, compared with conventional treatment (administration of drugs in the morning);Secondary Objective: Nocturnal bloodpressure treatment has a measurable effect on cardiovasculare risk factors, including left ventricular mass.

—

Secondary

Measure	Time frame
Secondary end point(s): Left ventricular mass Cardiac risk factors Vibrationperception threshold;Timepoint(s) of evaluation of this end point: 24 weeks	—

Countries

Denmark

Contacts

Public ContactKaren Lisa Hilsted

Rigshospitalet

karen.lisa.hilsted@rh.regionh.dk+4535459502

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 28, 2026