Comparison of Sevikar® and the Combination of Perindopril/Amlodipine on Central Blood Pressure

NCT01101009 | Completed Phase 4

• 2 other identifiers: DSE- SEV-02-092009-012966-30
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 15

Brief Summary

Comparison of the combination of amlodipine with an angiotensin receptor blocker or an angiotensin converting inhibitor, on central arterial blood pressure in patients with hypertension and additional risk factors. This is a randomised, double-blind, double-dummy, multicenter study. The duration of active treatment 24 weeks.

Conditions

Hypertension

Keywords

Sevikar®; Central Arterial Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Change in central systolic blood pressure from baseline (Week 0, Visit 0) to Final Examination (Week 24, Visit 5) using last observation carried forward approach.

  Baseline to week 24

Secondary Outcomes (7)

• Changes in systolic and diastolic ambulatory blood pressure (mean of 24h, daytime and night-time)

  Baseline to week 24

• Changes in conventional mean sitting systolic and diastolic blood pressure measurement

  Baseline to 24 weeks

• Incidence and profile of AEs separately by Run-in Phase and by double-blind Treatment Phase

  Run in phase (2 weeks) to end of study (24 weeks)

• Number of responders at Final Examination defined as normalized or a decrease of systolic blood pressure by at least 20 mmHg or diastolic blood pressure by at least 10 mmHg in conventional BP measurements.

  Baseline to 24 weeks

• Number of normalized at Final Examination (defined as blood pressure <140/90 mmHg or <130/80 mmHg in diabetics/chronic kidney disease, in conventional BP measurements.

  Baseline to 24 weeks

Study Arms (2)

Perindopril+amlodipine

ACTIVE COMPARATOR

Drug: Perindopril + amlodipine + if necessary, hydrochlorothiazide

Olmesartan/amlodipine

ACTIVE COMPARATOR

Drug: olmesartan/amlodipine + hydrochlorothiazide, if necessary.

Interventions

Perindopril + amlodipine + if necessary, hydrochlorothiazide DRUG

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

Perindopril+amlodipine

olmesartan/amlodipine + hydrochlorothiazide, if necessary. DRUG

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

Olmesartan/amlodipine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate to severe hypertension
• 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

You may not qualify if:

• secondary or malignant hypertension
• 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,

Sponsors & Collaborators

• Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company: lead

Study Sites (15)

Centro de Salud Casas Ibañez

Albacete, 02200, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital General de Jerez de la Frontera

Cadiz, 11407, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada (Madrid), Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario 12 Octubre

Madrid, 28041, Spain

Location

Hospital General Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario de Móstoles

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital General Carlos Haya

Málaga, Spain

Location

Centro de Salud Murcia San Andrés

Murcia, Spain

Location

Hospital de Sagunto

Puerto de Sagunto (Valencia), Spain

Location

Centro de Salud La Alamedilla

Salamanca, Spain

Location

Hospital Virgen de la Macarena

Seville, 41009, Spain

Location

Related Publications (2)

• 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.

  PMID: 24293132 DERIVED

• 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.

  PMID: 21586342 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Perindopril; Amlodipine; Hydrochlorothiazide; olmesartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 24, 2018

Record last verified: 2013-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

ES (15)