--- title: Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension nct_id: NCT00311155 overall_status: COMPLETED phase: PHASE4 sponsor: Sankyo Pharma Gmbh study_type: INTERVENTIONAL primary_condition: Essential Hypertension countries: Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Switzerland, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00311155.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00311155" ct_last_update_post_date: 2010-12-10 last_seen_at: "2026-05-12T06:45:11.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension **Official Title:** Treat-to-Target Study of Olmesartan Medoxomil and an Add-on Treatment Algorithm Consisting of Hydrochlorothiazide and Amlodipine Besylate in Patients With Mild to Moderate Hypertension **NCT ID:** [NCT00311155](https://clinicaltrials.gov/study/NCT00311155) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 694 - **Lead Sponsor:** Sankyo Pharma Gmbh - **Conditions:** Essential Hypertension - **Start Date:** 2006-03 - **Completion Date:** 2008-04 - **CT.gov Last Update:** 2010-12-10 ## Brief Summary This study is to assess the safety and efficacy of an add-on treatment algorithm with olmesartan, hydrochlorothiazide and amlodipine in patients with mild to moderate hypertension. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Male and female patients age greater than or equal to 18 years with mild to moderate hypertension. * Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough. Exclusion Criteria: * Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception. * Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases. * Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack. * Patients with clinically significant elevations in laboratory values at Screening Visit. * Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome. * Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate. ``` ## Arms - **1** (EXPERIMENTAL) — Olmesartan medoxomil oral tablets for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets for 8 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets + amlodipine oral tablets for 8 weeks ## Interventions - **olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary** (DRUG) — Olmesartan medoxomil oral tablets 20 mg for 4 weeks followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 12.5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 5 mg for 4 weeks, followed by, if necessary: Olmesartan medoxomil oral tablets 20 mg + hydrochlorothiazide oral tablets 25 mg + amlodipine oral tablets 10 mg for 4 weeks. All study medications are to be taken once daily. The subject's participation completes when blood pressure goals are achieved. ## Primary Outcomes - **The Percentage of Participants Treated to Target Blood Pressure Goals Overall and for Each Treatment Step From Baseline to Completion of Treatment During Which the Goal Was Achieved.** _(time frame: Baseline to ≤20 weeks)_ — For non-diabetic participants the target seated blood pressure goals were: Systolic - ≤130 mm Hg; Diastolic - ≤85 mm Hg. For diabetic participants the target seated blood pressure goals were: Systolic - \<130 mm Hg; Diastolic - \<80 mm Hg. ## Secondary Outcomes - **Percentage of Participants Who Achieved Normalized Blood Pressure Overall and for Each Treatment From Baseline to Completion of the Treatment During Which Blood Pressure Goals Were Achieved** _(time frame: Baseline to ≤20 weeks)_ - **Percentage of Participants Who Were Diastolic Responders Overall and for Each Treatment From Baseline to the Completion of Treatment During Which Blood Pressure Goals Were Achieved.** _(time frame: Baseline to ≤20 weeks)_ - **Percentage of Participants Who Were Systolic Responders Overall and for Each Treatment From Baseline to the Completion of the Treatment During Which Blood Pressure Goals Were Achieved** _(time frame: Baseline to ≤20 weeks)_ - **Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment** _(time frame: Baseline to ≤20 weeks)_ - **Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment** _(time frame: Baseline to ≤20 weeks)_ ## Locations (79) - Fulpmes, Austria - University Klinik, F. Innere Medizin, Innsbruck, Austria - Innsbruck, Austria - Kundl, Austria - Salzburg, Austria - Diakonissen-Krankenhaus Hospital, Salzburg-Aigen, Austria - Brussels, Belgium - Mechelen, Belgium - Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care, Seraing, Belgium - Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan, Temse, Belgium - Ancerville, France - Bourges, France - Derval, France - Grenoble, France - Lille, France - Montrevel-en-Bresse, France - Pouilly-en-Auxois, France - Poussan, France - Saint-Aubin-des-Châteaux, France - Saint-Étienne-de-Montluc, France - Saint-Priest, France - Sorcy-Saint-Martin, France - Strasbourg, France - Yerres, France - Annweiler am Trifels, Germany - Balve, Germany - Bammental, Germany - Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I, Bielefeld, Germany - Uniklinik Bonn, Bonn, Germany - Goch, Germany - Haag, Germany - Hamburg, Germany - Heidelberg, Germany - Heidelberg (Neuenheim), Germany - Mühldorf / Inn, Germany - Schwenningen, Germany - VS-Villingen, Germany - Weyhe, Germany - Ospedale Regina Apostolorum, Albano Laziale (RM), Italy - Ospedale C.G. Mazzoni, Ascoli Piceno, Italy - Ospedale Nuovo Cutroni, Barcellona Pozzo Di Gotto (ME), Italy - Casa di Cura "La Madonnina", Bari, Italy - Ospedale San Sebastiano, Caserta, Italy - Ospedale Vittorio Emanuele, Catania, Italy - Università degli Studi "G. D'Annunzio", Chieti Scalo, Italy - Azienda Ospedaliera "Madonna delle Grazie", Matera, Italy - Ospedale San Paolo, Milan, Italy - Ospedale San Carlo Borromeo, Milan, Italy - Presidio Ospedaliero San Lorenzo, Palermo, Italy - Presidio Ospedaliero di Portogruaro, Portogruaro (VE), Italy - Azienda Policlinico Universitario a Gestione Diret, Udine, Italy - 's-Hertogenbosch, Netherlands - Maxima Medisch Centrum, Eindhoven, Netherlands - H. Elvas, Elvas, Netherlands - Hilversum, Netherlands - Lieshout, Netherlands - Waalwijk, Netherlands - H. Almada, Almada Almada, Portugal - Hospital Fernando da Fonseca, Amadora Amadora, Portugal - Hospital de. S. Marta, Lisboa Lisboa, Portugal - Zentrum Oberdorf, Affoltern am Albis, Switzerland - Bellinzona, Switzerland - Gland, Switzerland - Petit Lancy, Switzerland - Praxis Dreispitz, Zurich, Switzerland - The Atherstone Surgery, Atherstone, United Kingdom - The Medical Centre, Birmingham, United Kingdom - Waterloo Medical Centre, Blackpool, United Kingdom - Rowden Surgery, Chippenham, United Kingdom - The Gables Medical Centre, Coventry, United Kingdom - Bridge Medical Centre, Crawley, United Kingdom - Homefield Surgery, Exeter, United Kingdom - Woodside Health Centre, Glasgow, United Kingdom - Castle Milk Health Centre, Glasgow, United Kingdom - Division of Cardiovascular and Endocrine Sciences, Manchester, United Kingdom - University of Manchester, Manchester, United Kingdom - Oakside Surgery, Plymouth, United Kingdom - Norwood Medical Centre, Sheffield, United Kingdom - Lovemead Group Practice, Trowbridge, United Kingdom ## Recent Field Changes (last 30 days) - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.|kundl||austria` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|fulpmes||austria` — added _(2026-05-12)_ - `locations.university klinik, f. innere medizin|innsbruck||austria` — added _(2026-05-12)_ - `locations.|innsbruck||austria` — added _(2026-05-12)_ - `locations.|salzburg||austria` — added _(2026-05-12)_ - `locations.diakonissen-krankenhaus hospital|salzburg-aigen||austria` — added _(2026-05-12)_ - `locations.|brussels||belgium` — added _(2026-05-12)_ - `locations.|mechelen||belgium` — added _(2026-05-12)_ - `locations.centre hospitalier du bois de l'abbaye et de hesba, department of intensive care|seraing||belgium` — added _(2026-05-12)_ - `locations.allgemeen ziekenhuis maria-middelares, cardiologie, campus de pelikaan|temse||belgium` — added _(2026-05-12)_ - `locations.|ancerville||france` — added _(2026-05-12)_ - `locations.|bourges||france` — added _(2026-05-12)_ - `locations.|derval||france` — added _(2026-05-12)_ - `locations.|grenoble||france` — added _(2026-05-12)_ - `locations.|lille||france` — added _(2026-05-12)_ - `locations.|montrevel-en-bresse||france` — added _(2026-05-12)_ - `locations.|pouilly-en-auxois||france` — added _(2026-05-12)_ - `locations.|poussan||france` — added _(2026-05-12)_ - `locations.|saint-aubin-des-châteaux||france` — added _(2026-05-12)_ - `locations.|saint-étienne-de-montluc||france` — added _(2026-05-12)_ - `locations.|saint-priest||france` — added _(2026-05-12)_ - `locations.|sorcy-saint-martin||france` — added _(2026-05-12)_ - `locations.|strasbourg||france` — added _(2026-05-12)_ - `locations.|yerres||france` — added _(2026-05-12)_ - `locations.|annweiler am trifels||germany` — added _(2026-05-12)_ - `locations.|balve||germany` — added _(2026-05-12)_ - `locations.|bammental||germany` — added _(2026-05-12)_ - `locations.ev. krankenhaus bielefeld, medizinische klinik in bethel - gilead i|bielefeld||germany` — added _(2026-05-12)_ - `locations.uniklinik bonn|bonn||germany` — added _(2026-05-12)_ - `locations.|goch||germany` — added _(2026-05-12)_ - `locations.|haag||germany` — added _(2026-05-12)_ - `locations.|hamburg||germany` — added _(2026-05-12)_ - `locations.|heidelberg||germany` — added _(2026-05-12)_ - `locations.|heidelberg (neuenheim)||germany` — added _(2026-05-12)_ - `locations.|mühldorf / inn||germany` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00311155.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00311155* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*