Hydrochlorothiazide as add-on to Olmesartan/Amlodipine in Hypertension
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
Timeline
- Start
- 2009-04
- Primary completion
- 2010-09
- Completion
- 2010-10
Outcome
Mixed primary results
registry LEAST_SQUARES_MEAN OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5: -7.1 (Standard Error 0.55) mm Hg NCT00902538 ↗
registry analysis (superiority or other test); Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg vs OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5; p = 0.1187; ANCOVA NCT00902538 ↗
registry LEAST_SQUARES_MEAN OLM 40-AML 10-HCTZ 25: -8.9 (Standard Error 0.55) mm Hg NCT00902538 ↗
registry analysis (superiority or other test); Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg vs OLM 40-AML 10-HCTZ 25; p <0.0001; ANCOVA NCT00902538 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrochlorothiazide | Unknown | 12.5 mg | Oral |
| Subject | Hydrochlorothiazide | Unknown | 25 mg | Oral |
| Background | Amlodipine | Other / unclassified | 10 mg | Oral |
| Background | Olmesartan medoxomil | Unknown | 40 mg | Oral |