Phase 4 N=105 Randomized Treatment

Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00858702 ↗

Enrolled (actual)

105

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85 — 34.0; 59.2 Percent of participants — p=0.0158

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: olmesartan medoxomil and a CCB (Drug); olmesartan medoxomil and a diuretic (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Daiichi Sankyo Co., Ltd.
Primary completion: Jul 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85	34.0; 59.2	0.0158 sig
SECONDARY Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)	0; 7.7	0.0566
SECONDARY Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)	1.9; 44.2	<0.001 sig

Summary

The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone

Eligibility Criteria

Inclusion Criteria

Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil

Exclusion Criteria

Patients with secondary hypertension
Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

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Data sourced from ClinicalTrials.gov (NCT00858702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.