Comparison of Sevikar® and the Combination of Perindopril/Amlodipine on Central Blood Pressure
NCT ID: NCT01101009
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
486 participants
INTERVENTIONAL
2010-04-30
2012-12-31
Brief Summary
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Detailed Description
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Male and female Caucasians aged ≥ 40 years and \<80 years with moderate to severe hypertension, defined by a systolic blood pressure (SBP) ≥ 160 and ≤ 200 or diastolic blood pressure (DBP) ≥ 100 and ≤ 115 mmHg for untreated patients, SBP ≥ 140 or DBP ≥ 90 mmHg for insufficiently pre-treated patients and SBP ≥ 130 mmHg or DBP ≥ 80 mmHg for insufficiently pretreated diabetics chronic kidney disease will be eligible for participation. In addition,three additional risk factors should be present.
During the course of the study three central blood pressure measurements (at randomization, at week 12 and at termination) will be performed with SphygmoCor ultrasound method. The conventional measurements with calibrated tensiometers (Omron) will be performed at each visit. Ambulatory blood pressure monitoring will be performed at randomisation.
The study starts with a 2-4 week run in phase. AM will be given as open-labelled 5 mg or 10 mg tablets, administered once daily. After randomization during the double-blind phase, study medication will comprise either OM/AM 40/10 mg or PER 8 mg (2x4 mg) plus AM 10 mg and will be administered once daily. Furthermore, open-label HCTZ 12.5 mg and 25.0 mg will be provided in tablets and administered once daily according to the treatment schedule.
The primary endpoint is the change in central SBP from baseline (Week 0, Visit 0) to final examination (Week 24, Visit 5) using Last Observation Carried Forward (LOCF) approach.
The study is conducted in approximately 15 centres in Spain. Depending on the previously administered drugs the run in phase is up to four weeks (Visits -2 and -1). Individual duration of active treatment (after randomization) will last 24 weeks (Visits 0-5). The total individual duration is 28 weeks.
A total of 518 patients (259 patients/arm) will be needed in the Per Protocol Set (PPS) for the confirmatory primary analysis using mean change from baseline (Week 0) to Final Examination assuming a drop out rate of 20% during Run-in Phase a total of 720 patients have to be screened in order to achieve 576 (288 patients/arm) randomised patients.
Assuming approximately 10% major protocol deviations, a total of 518 patients will remain in the PPS.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Perindopril+amlodipine
Perindopril + amlodipine + if necessary, hydrochlorothiazide
Two perindopril 4 mg tablets + 1 amlodipine 10 mg tablet + placebo tablet matching the olmesartan/amlodipine tablet. All tablets are taken once daily. The duration of administration of perindopril tablets and placebo is 24 weeks. The duration of administration of amlodipine tablets is 24-26 weeks. Hydrochlorthiazide tablets 12.5 mg or 25 mg, once daily, will be added, if necessary
Olmesartan/amlodipine
olmesartan/amlodipine + hydrochlorothiazide, if necessary.
olmesartan/amlodipine tablets 40 mg/10 mg, + placebo tablets matching the perindopril tablet and amlodipine tablet. All tablets are taken once daily for 24 weeks. Hydrochlorthiazide tablets 12.5 mg or 25 mg, once daily, will be added, if necessary
Interventions
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Perindopril + amlodipine + if necessary, hydrochlorothiazide
Two perindopril 4 mg tablets + 1 amlodipine 10 mg tablet + placebo tablet matching the olmesartan/amlodipine tablet. All tablets are taken once daily. The duration of administration of perindopril tablets and placebo is 24 weeks. The duration of administration of amlodipine tablets is 24-26 weeks. Hydrochlorthiazide tablets 12.5 mg or 25 mg, once daily, will be added, if necessary
olmesartan/amlodipine + hydrochlorothiazide, if necessary.
olmesartan/amlodipine tablets 40 mg/10 mg, + placebo tablets matching the perindopril tablet and amlodipine tablet. All tablets are taken once daily for 24 weeks. Hydrochlorthiazide tablets 12.5 mg or 25 mg, once daily, will be added, if necessary
Eligibility Criteria
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Inclusion Criteria
* 3 additional risk factors such as age \> 55 (male), \> 65 female, smoker, type 2 diabetes, obesity, cardiovascular disease, congestive heart failure, chronic kidney disease,
* ability to give informed consent
Exclusion Criteria
* contraindication to any of the study drugs
* Creatinine clearance level \<40ml/min
* treatment with more than 3 antihypertensive drugs
* Myocardial infarction, percutaneous transluminal coronary angioplasty, cardiac bypass surgery \< 6 month prior to start of the study,
* unstable angina pectoris,
* stroke, transient ischemic attack \< 3 months prior to start,
* Congestive heart failure NYHA II-IV,
* clinically relevant concomitant diseases,
* alcohol or drug abuse,
* pregnancy or women of childbearing potential without contraceptive precaution,
40 Years
80 Years
ALL
No
Sponsors
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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
INDUSTRY
Responsible Party
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Locations
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Centro de Salud Casas Ibañez
Albacete, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital General de Jerez de la Frontera
Cadiz, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada (Madrid), , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario 12 Octubre
Madrid, , Spain
Hospital General Universitario La Paz
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario de Móstoles
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital General Carlos Haya
Málaga, , Spain
Centro de Salud Murcia San Andrés
Murcia, , Spain
Hospital de Sagunto
Puerto de Sagunto (Valencia), , Spain
Centro de Salud La Alamedilla
Salamanca, , Spain
Hospital Virgen de la Macarena
Seville, , Spain
Countries
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References
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Ruilope L, Schaefer A. The fixed-dose combination of olmesartan/amlodipine was superior in central aortic blood pressure reduction compared with perindopril/amlodipine: a randomized, double-blind trial in patients with hypertension. Adv Ther. 2013 Dec;30(12):1086-99. doi: 10.1007/s12325-013-0076-6. Epub 2013 Nov 30.
Ruilope LM, Schaefer A. Efficacy of Sevikar(R) compared to the combination of perindopril plus amlodipine on central arterial blood pressure in patients with moderate-to-severe hypertension: Rationale and design of the SEVITENSION study. Contemp Clin Trials. 2011 Sep;32(5):710-6. doi: 10.1016/j.cct.2011.04.011. Epub 2011 May 14.
Other Identifiers
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2009-012966-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DSE- SEV-02-09
Identifier Type: -
Identifier Source: org_study_id