Clinical trial NCT00902538
Conditions: Essential Hypertension
Keywords: Add on treatment essential hypertension
Sponsor: Daiichi Sankyo
Start date: 2009-04-01; Completion date: 2010-10-01
Enrollment: 2204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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

Detailed description:

Arms: arm 1: The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2. arm 2: Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3. arm 3: Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. arm 4: Participants who meet their blood pressure goals in Period 3 and continued into the 8-week, double-blind Period 4 continued to receive this combination. arm 5: Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4 arm 6: Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
Interventions: intervention 1: Olmesartan medoxomil 40 mg - Amlodipine 10 mg intervention 2: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 12.5mg intervention 3: Olmesartan 40mg-Amlodipine 10mg-Hydrochlorothiazide 25mg intervention 4: OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg intervention 5: OLM 40mg-AML 10mg-Hydrochlorothiazide 12.5mg intervention 6: OLM 40mg-AML 10mg-Hydrochlorothiazide 25mg
Intervention descriptions: intervention 1: Oral tablets containing Olmesartan medoxomil-Amlodipine 40-10 mg, given once daily intervention 2: 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. intervention 3: Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablets. All tablets are given once a day. intervention 4: 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. intervention 5: 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. intervention 6: Coated, oral tablets containing Olmesartan 40mg-Amlodipine 10mg + 2 Hydrochlorothiazide 12.5mg oral tablet. All tablets are given once a day.

Protocol documents: