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Amlodipine as Add-on to Olmesartan in Hypertension

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00220220
First received: September 16, 2005
Last updated: October 10, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention Phase
Essential Hypertension
 Drug: olmesartan medoxomil
Drug: amlodipine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

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

Estimated Enrollment: 429
Study Start Date: April 2005
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220220

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

No publications provided

ClinicalTrials.gov Identifier: NCT00220220     History of Changes
Other Study ID Numbers: CS8663-A-E302
Study First Received: September 16, 2005
Last Updated: October 10, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Olmesartan medoxomil
Olmesartan
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013