Amlodipine as add-on to Olmesartan in Hypertension

• ClinicalTrials.gov Identifier: NCT00220220
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Last Update Posted: December 24, 2018
• Sponsor: Sankyo Pharma Gmbh
• Information provided by: Daiichi Sankyo, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Essential Hypertension	Drug: olmesartan medoxomil; Drug: amlodipine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 429 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: April 2005
• Actual Study Completion Date: April 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.
2. Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.
3. Safety and tolerability

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Germany

Hamburg, Germany

Magdeburg, Germany

Messkirch, Germany

Stuhr, Germany

Tann, Germany

Worpswede, Germany

Sponsors and Collaborators

Sankyo Pharma Gmbh

Investigators

• Principal Investigator: Peter Brommer, MD

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• ClinicalTrials.gov Identifier: NCT00220220
• Other Study ID Numbers: CS8663-A-E302
• First Posted: September 22, 2005
• Last Update Posted: December 24, 2018
• Last Verified: October 2007

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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/
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.
• URL: https://vivli.org/ourmember/daiichi-sankyo/

Additional relevant MeSH terms:

Hypertension; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases; Amlodipine; Olmesartan; Olmesartan Medoxomil; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists