SEVICONTROL-2: Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial

SEVICONTROL-2: Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial - Sevicontrol-2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004249-42-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 hypertension 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-

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 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 • parallel participation in other clinical trials

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy in blood significantly improved blood pressure reduction after six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg as compared to monotherapy with 32 mg candesartan and safety of sequential therapy change via 6 weeks monotherapy with olmesartan;Secondary Objective: Comparison of OBDM and ABPM values with regard to achieving target bp values. Distribution of patients over different ABPM dipping regimes.;Primary end point(s): Reduction in systolic daytime mean ABDM values after six weeks therapy with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan;Timepoint(s) of evaluation of this end point: After 6 weeks monotherapy with olmesartan followed by six weeks under therapy with the fixed combination.	—

Measure

Time frame

Main Objective: Efficacy in blood significantly improved blood pressure reduction after six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg as compared to monotherapy with 32 mg candesartan and safety of sequential therapy change via 6 weeks monotherapy with olmesartan;Secondary Objective: Comparison of OBDM and ABPM values with regard to achieving target bp values. Distribution of patients over different ABPM dipping regimes.;Primary end point(s): Reduction in systolic daytime mean ABDM values after six weeks therapy with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan;Timepoint(s) of evaluation of this end point: After 6 weeks monotherapy with olmesartan followed by six weeks under therapy with the fixed combination.

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Secondary

Measure	Time frame
Secondary end point(s): Reduction of systolic/diastolic office blood pressure and mean values (night-time and 24 h for systolic bp and day-time, night-time and 24 h for diastolic bp) after therapy change from candesartan to a fixed combination of olmesartan 40 mg and amlodipine 10 mg. Comparison of office bp and ABPM measurements with regard to achieving the target bp values (<140/90 mmHg for OBPM; < 135/85 mmHg for mean day-time ABPM value).;Timepoint(s) of evaluation of this end point: After 6 weeks monotherapy with olmesartan followed by six weeks under therapy with the fixed combination.	—

Measure

Time frame

Secondary end point(s): Reduction of systolic/diastolic office blood pressure and mean values (night-time and 24 h for systolic bp and day-time, night-time and 24 h for diastolic bp) after therapy change from candesartan to a fixed combination of olmesartan 40 mg and amlodipine 10 mg. Comparison of office bp and ABPM measurements with regard to achieving the target bp values (<140/90 mmHg for OBPM; < 135/85 mmHg for mean day-time ABPM value).;Timepoint(s) of evaluation of this end point: After 6 weeks monotherapy with olmesartan followed by six weeks under therapy with the fixed combination.

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Countries

Germany

Contacts

Public ContactIPPMed

IPPMed GmbH

peter.bramlage@ippmed.de+49033793148790

Outcome results

None listed

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

SEVICONTROL-2: Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results