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Amlodipine as add-on to Olmesartan in Hypertension

Primary Purpose

Essential Hypertension

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

olmesartan medoxomil

amlodipine

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization. Exclusion Criteria: Secondary hypertension of any aetiology; Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s); History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.

Sites / Locations

Outcomes

Primary Outcome Measures

Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.

Secondary Outcome Measures

Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.

Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.

Safety and tolerability

Full Information

NCT ID

NCT00220220

First Posted

September 16, 2005

Last Updated

December 20, 2018

Sponsor

Sankyo Pharma Gmbh

1. Study Identification

Unique Protocol Identification Number

NCT00220220

Brief Title

Amlodipine as add-on to Olmesartan in Hypertension

Official Title

Efficacy and Safety of Amlodipine Used as add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sankyo Pharma Gmbh

4. Oversight

5. Study Description

Brief Summary

Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

429 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

olmesartan medoxomil

Intervention Type

Drug

Intervention Name(s)

amlodipine

Primary Outcome Measure Information:

Title

Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.

Secondary Outcome Measure Information:

Title

Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.

Title

Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.

Title

Safety and tolerability

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Brommer, MD

Official's Role

Principal Investigator

Facility Information:

City

Hamburg

Country

Germany

City

Magdeburg

Country

Germany

City

Messkirch

Country

Germany

City

Stuhr

Country

Germany

City

Tann

Country

Germany

City

Worpswede

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

https://vivli.org/ourmember/daiichi-sankyo/

Citations:

PubMed Identifier

19499960

Citation

Barrios V, Brommer P, Haag U, Calderon A, Escobar C. Olmesartan medoxomil plus amlodipine increases efficacy in patients with moderate-to-severe hypertension after monotherapy: a randomized, double-blind, parallel-group, multicentre study. Clin Drug Investig. 2009;29(7):427-439. doi: 10.2165/00044011-200929070-00001.

Results Reference

derived

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Amlodipine as add-on to Olmesartan in Hypertension

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