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

NCT01611077 | Completed Phase 4 DMC

• 1 other identifier: Sevicontrol-2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

  after 6 and 12 weeks

Study Arms (1)

Single Arm

OTHER

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; Drug: Olmesartan medoxomil; Drug: Olmesartan/amlodipine

Interventions

Candesartan cilexetil DRUG

Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days

Also known as: Atacand

Single Arm

Olmesartan medoxomil DRUG

Switch to olmesartan 40 mg tablets once daily for 42 days,

Also known as: Olmetec

Single Arm

Olmesartan/amlodipine DRUG

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

Also known as: Sevikar (r)

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (11)

Praxis Dr. Reimer

Anderbeck, 38836, Germany

Location

Praxis Dr. Heinz

Bergisch Gladbach, 51429, Germany

Location

Praxis Dr. Zemmrich

Berlin, 12043, Germany

Location

St.-Josefs-Hospital

Cloppenburg, 49661, Germany

Location

Praxis Dr. Pohl

Dresden, 01129, Germany

Location

Praxis Dr. Koßler-Wiesweg

Essen, 45138, Germany

Location

Praxis Dr. Rövenich

Frankfurt, 65929, Germany

Location

Praxis Dr. Strzata

Kapellendorf, 99510, Germany

Location

Praxis Dr. Paschmionka

Leipzig, 04316, Germany

Location

Praxis Dr. Pitule

Ludwigshafen, 67061, Germany

Location

Praxis Dr. Loddo

Rastede, 26180, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil; Olmesartan Medoxomil; olmesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines

Study Officials

• Stephan Lüders, Dr.med.

  St.-Josefs-Hospital Cloppenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 4, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

DE (11)