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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Candesartan cilexetil; Drug: Olmesartan medoxomil; Drug: Olmesartan/amlodipine

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

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Anderbeck, Germany, 38836
    • Praxis Dr. Reimer
  • Bergisch-Gladbach, Germany, 51429
    • Praxis Dr. Heinz
  • Berlin, Germany, 12043
    • Praxis Dr. Zemmrich
  • Cloppenburg, Germany, 49661
    • St.-Josefs-Hospital
  • Dresden, Germany, 01129
    • Praxis Dr. Pohl
  • Essen, Germany, 45138
    • Praxis Dr. Koßler-Wiesweg
  • Frankfurt, Germany, 65929
    • Praxis Dr. Rövenich
  • Kapellendorf, Germany, 99510
    • Praxis Dr. Strzata
  • Leipzig, Germany, 04316
    • Praxis Dr. Paschmionka
  • Ludwigshafen, Germany, 67061
    • Praxis Dr. Pitule
  • Rastede, Germany, 26180
    • Praxis Dr. Loddo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• systolic office bp > 180 mm Hg at screening visit
• known hypertensive retinopathy GIII or IV
• recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
• type I diabetes or poorly controlled (HbA1c >= 8) type II diabetes
• chronic heart failure NYHA III or IV
• prior stroke or TIA
• creatinine clearance < 60 ml/min or condition after kidney transplant
• moderately or severely impaired liver function (ALT or AST or bilirubin more than double normal value)
• women of childbearing potential without highly effective contraception, pregnant or breastfeeding women
• concomitant therapy with lithium
• hemodynamically relevant mitral or aortic valve stenosis (>= 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single Arm; Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days, then olmesartan 40 mg tablets once daily for 42 days, then olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days

Drug: Candesartan cilexetil; Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days; Other Names: Atacand; Drug: Olmesartan medoxomil; Switch to olmesartan 40 mg tablets once daily for 42 days,; Other Names: Olmetec; 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; Other Names: Sevikar (r)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values	After six weeks therapy with a monotherapy with olmesartan 40 mg and further six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan.	ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic/diastolic office blood pressure and mean values (night-time and 24 hr for systolic bp and day-time, night-time and 24 hr for diastolic bp)	from candesartan to olmesartan 40 mg and then to a fixed combination of olmesartan 40 mg and amlodipine 10 mg.	after 6 and 12 weeks

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Investigators: Principal Investigator: Stephan Lüders, Dr.med., St.-Josefs-Hospital Cloppenburg

Publications and helpful links

Helpful Links

• Results Publication

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (Estimate): June 4, 2012

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Olmesartan; Olmesartan Medoxomil; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: Sevicontrol-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided