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Assessment of the effects on 24-hour ambulatory blood pressure and the safety of a once-a-day oral 8 mg perindopril morning administration versus evening administration in hypertensive patients. An 8-week, 2-arm, randomised, double-blind study.

Assessment of the effects on 24-hour ambulatory blood pressure and the safety of a once-a-day oral 8 mg perindopril morning administration versus evening administration in hypertensive patients. An 8-week, 2-arm, randomised, double-blind study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-007026-22-CZ
Enrollment
500
Registered
2008-03-28
Start date
2008-03-28
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Essential arterial hyperpertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension

Interventions

Trade Name: COVERSYL 4mg Pharmaceutical Form: Tablet INN or Proposed INN: Perindopril Concentration unit: mg milligram(s) Concentration type: equal Concentration number: -4 Pharmaceutical form of the

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Essential hypertension after institution of appropriate healthy lifestyle modification, measured with a validated automatic measurement device in the medical office in supine position: 95 = DBP =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Kalaemia = local laboratory's high normal values Positive pregnancy test for non menopausal women Creatinine = 150 mmol/l or creatinine clearance < 60 ml/mn, using Cockroft's formula

Design outcomes

Primary

MeasureTime frame
Secondary Objective: - To assess difference between the two treatment groups on other ABPM periods and parameters - Safety and tolerability ;Primary end point(s): Mean change in daytime-ABPM DBP.;Main Objective: To assess a 38h-ABPM the blood pressure decrease (DBP during daytime) from baseline to study end with a validated ABPM device, after an 8-week treatment period with perindopril, administered either at 8:00 am or at 8:00 pm.—

Countries

Czech Republic

Outcome results

None listed

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