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

• Conditions: essential hypertension; MedDRA version: 7.0Level: LLTClassification code 10015488

• Registration Number: EUCTR2005-000447-28-DE
• Lead Sponsor: Sankyo Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-29
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

Male and female patients at the age of 18 years or above with moderate to severe hypertension defined as a mean sitting sBP of 160 mmHg and a mean sitting dBP of 100 mmHg not on antihypertensive medication and a mean 24-hour dBP assessed by 24h-ABPM of at least 84 mmHg and with at least 30% of daytime dBP readings above 90 mmHg at Visit 2 (at the end of the taper-off period) will enter Period I.

Eligible patients who at Screening are already taking a stable dose of OM 20 mg or OM 40 mg for at least four weeks have to fulfil the following criteria before entering directly into Period I: previously suffered from moderate to severe hypertension (before first intake of OM 20 mg or OM 40 mg) mean sitting sBP 140 mmHg and mean sitting dBP 90 mmHg at Screening a mean 24-hour dBP of at least 80 mmHg assessed by 24h-ABPM and with at least 30% of daytime dBP readings over 85 mmHg.

To be randomised to Period II, the mean 24-hour dBP assessed by 24h-ABPM must be at least 80 mmHg and at least 30% of the daytime dBP readings must be above 85 mmHg. Furthermore, the overall mean trough sitting dBP must be between 90 mmHg and 115 mmHg inclusive and the overall mean trough sitting sBP must be 140 mmHg (at Visit 4/Week 8, conventional BP measurements).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Female patients of childbearing potential must not be pregnant or lactating. Female patients of childbearing potential must be using adequate contraception.

- Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases.

- Patients having a history of the following within the last six months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke) or transient ischaemic attack.

- Patients with clinically significant elevations of laboratory values at Screening.

- Patients with secondary hypertension of any aetiology such as renal disease, pheochromocytoma or Cushing’s syndrome.

- Patients with contraindication to amlodipine and/or olmesartan medoxomil.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified