NCT00902538

Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension

Add-on Study of Hydrochlorothiazide in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Olmesartan/Amlodipine Alone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,204 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive patients whose blood pressure is not adequately controlled with OLM/AML alone. The following treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg; OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used are as follows: Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Olmesartan medoxomil 40 mg - Amlodipine 10 mg	Oral tablets containing Olmesartan medoxomil-Amlodipine 40-10 mg, given once daily
DRUG	Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg	Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
DRUG	Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg	Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablets. All tablets are given once a day.
DRUG	OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg	Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
DRUG	OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg	Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 1 Hydrochlorothiazide 12.5mg oral tablet + 1 Hydrochlorothiazide 12.5mg oral, placebo tablet. All tablets are given once a day.
DRUG	OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg	Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablet. All tablets are given once a day.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2009-05-15
• Last updated: 2019-01-11
• Results posted: 2011-11-22

Locations

117 sites across 14 countries: Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Netherlands, Poland, Romania, Russia, Slovakia, Spain, Ukraine