Amlodipine as add-on to Olmesartan in Hypertension

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220220
• Other study ID #: CS8663-A-E302
• Status: Completed
• Phase: Phase 3
• Start date: April 2005
• Est. completion date: April 2007

Study information

• Verified date: October 2007
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• olmesartan medoxomil

• amlodipine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sankyo Pharma Gmbh

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.
Secondary	Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.
Secondary	Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.
Secondary	Safety and tolerability