NCT01611077

Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators want to find out if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve comparable baseline conditions. Treatment is then started with the single substance. After six weeks, therapy is changed to another single substance and after a further six weeks, to the fixed combination tablet. Blood pressure is determined by office measurements taken by the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be male or female and must be over 18 years of age.

Detailed description

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

• Hypertension

Interventions

Type	Name	Description
DRUG	Candesartan cilexetil	Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days
DRUG	Olmesartan medoxomil	Switch to olmesartan 40 mg tablets once daily for 42 days,
DRUG	Olmesartan/amlodipine	then switch to olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2012-06-04
• Last updated: 2017-02-23

Locations

11 sites across 1 country: Germany