FindTrial
Sign In

SEVICONTROL-1: Efficacy and safety of a fixed combination of olmesartan 40 mg/amlodipin 10 mg in patients with moderate essential hypertension not sufficiently controlled under monotherapy with candesartan 32 mg - an open phase IIIb trial

SEVICONTROL-1: Efficacy and safety of a fixed combination of olmesartan 40 mg/amlodipin 10 mg in patients with moderate essential hypertension not sufficiently controlled under monotherapy with candesartan 32 mg - an open phase IIIb trial - SEVICONTROL-1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004235-31-DE
Enrollment
Unknown
Registered
2011-09-22
Start date
2011-12-09
Completion date
Unknown
Last updated
2013-05-06

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

Conditions

moderate essential arterial hypertension MedDRA version: 14.0 Level: LLT Classification code 10015491 Term: Essential hypertension, unspecified System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: Atacand 16 mg Pharmaceutical Form: Tablet INN or Proposed INN: CANDESARTAN CAS Number: 139481-59-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 16-

Sponsors

IPPMed GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: male or female patients >= 18 years of age essential hypertension, i. e. systolic office bp >= 140 mmHg for pre-treated patients or >= 160 mmHg for untreated patients at screening visit and >= 160 mmHg at end of wash-out signed IC 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • systolic office bp > 180 mm Hg at screening visit • known hypertensive retinopathy GIII or IV • recent ( 8) type II diabetes • chronic heart failure NYHA III or IV • prior stroke or TIA • creatinine clearance = II°) or hypertrophic obstructive cardiomyopathy • concomitant therapy with strong CYP3A4 inhibitors or inductors • african patients • concomitant severe psychiatric condition that might impair proper intake of study medication • life expectancy < 6 months • night shift workers • known other mandatory indication for treatment with antihypertensive medications

Design outcomes

Primary

MeasureTime frame
Main Objective: Efficacy in blood pressure reduction and safety of a direct switch from candesarten to a fixed combination of olmesartan and amlodipin.;Secondary Objective: Comparison of evening to morning application of olmesartan 40 mg/amlodipin 10 mg with regard to improving the circadian blood pressure profile and the safety of the fixed combination. ;Primary end point(s): Reduction in systolic day-time mean APBM values after 6 weeks treatment with the fixed combination of 40 mg olmesartan and 10 mg amlodipin as compared to previous monotherapy with candesartant;Timepoint(s) of evaluation of this end point: 6 weeks after switch from candesartan monotherapy to treatment with fixed combination—

Secondary

MeasureTime frame
Secondary end point(s): reduction of the ratio of non-dippers/inverted dippers ;Timepoint(s) of evaluation of this end point: 6 weeks after switching from morning to evening intake of the fixed combination of olmesartan 40 mg and amlodipine 10 mg—

Countries

Germany

Contacts

Public ContactIPPMed

IPPMed GmbH

peter.bramlage@ippmed.de+49033793147890

Outcome results

None listed

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