Amlodipine as add-on to Olmesartan in Hypertension

Phase 3CompletedNCT00220220

Sankyo Pharma Gmbh429 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

429

Conditions

Essential Hypertension

Interventions

olmesartan medoxomilDRUG

amlodipineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Unnamed facility

Hamburg, Germany

Unnamed facility

Magdeburg, Germany

Unnamed facility

Messkirch, Germany

Unnamed facility

Stuhr, Germany

Unnamed facility

Tann, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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