Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension

NCT00311155 | Completed Phase 4 Results

• 2 other identifiers: SP-OLM-03-052005-004659-36
• Study Type: interventional
• Target: 694
• Locations: 9 countries
• Sites: 79

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.

Conditions

Essential Hypertension

Keywords

Olmesartan medoxomil; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline to ≤20 weeks

Secondary Outcomes (5)

• 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

  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.

  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

  Baseline to ≤20 weeks

• Mean Change in Diastolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment

  Baseline to ≤20 weeks

• Mean Change in Systolic Blood Pressure Overall and for Each Treatment From Baseline to the Completion of the Treatment

  Baseline to ≤20 weeks

Study Arms (1)

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

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sankyo Pharma Gmbh: lead

Study Sites (79)

Unknown Facility

Fulpmes, 6166, Austria

Location

University Klinik, F. Innere Medizin

Innsbruck, 6020, Austria

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Kundl, 6250, Austria

Location

Unknown Facility

Salzburg, 5020, Austria

Location

Diakonissen-Krankenhaus Hospital

Salzburg-Aigen, 5026, Austria

Location

Unknown Facility

Brussels, 1080, Belgium

Location

Unknown Facility

Mechelen, 2800, Belgium

Location

Centre Hospitalier du Bois de l'Abbaye et de Hesba, Department of Intensive Care

Seraing, 4100, Belgium

Location

Allgemeen Ziekenhuis Maria-Middelares, Cardiologie, Campus de Pelikaan

Temse, 9140, Belgium

Location

Unknown Facility

Ancerville, 55170, France

Location

Unknown Facility

Bourges, 18000, France

Location

Unknown Facility

Derval, 44590, France

Location

Unknown Facility

Grenoble, 38100, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Montrevel-en-Bresse, 01340, France

Location

Unknown Facility

Pouilly-en-Auxois, 21320, France

Location

Unknown Facility

Poussan, 34560, France

Location

Unknown Facility

Saint-Aubin-des-Châteaux, 44110, France

Location

Unknown Facility

Saint-Étienne-de-Montluc, 44360, France

Location

Unknown Facility

Saint-Priest, 69800, France

Location

Unknown Facility

Sorcy-Saint-Martin, 55190, France

Location

Unknown Facility

Strasbourg, 67000, France

Location

Unknown Facility

Yerres, 91330, France

Location

Unknown Facility

Annweiler am Trifels, 76855, Germany

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Unknown Facility

Balve, 58802, Germany

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Unknown Facility

Bammental, 69245, Germany

Location

Ev. Krankenhaus Bielefeld, Medizinische Klinik in Bethel - Gilead I

Bielefeld, 33617, Germany

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Uniklinik Bonn

Bonn, 53111, Germany

Location

Unknown Facility

Goch, 47574, Germany

Location

Unknown Facility

Haag, 83527, Germany

Location

Unknown Facility

Hamburg, 20148, Germany

Location

Unknown Facility

Heidelberg, 69115, Germany

Location

Unknown Facility

Heidelberg (Neuenheim), 69120, Germany

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Unknown Facility

Mühldorf / Inn, 84453, Germany

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Unknown Facility

Schwenningen, 78054, Germany

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Unknown Facility

VS-Villingen, 78050, Germany

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Unknown Facility

Weyhe, 28844, Germany

Location

Ospedale Regina Apostolorum

Albano Laziale (RM), 00041, Italy

Location

Ospedale C.G. Mazzoni

Ascoli Piceno, 63100, Italy

Location

Ospedale Nuovo Cutroni

Barcellona Pozzo Di Gotto (ME), 98051, Italy

Location

Casa di Cura "La Madonnina"

Bari, 70124, Italy

Location

Ospedale San Sebastiano

Caserta, 81100, Italy

Location

Ospedale Vittorio Emanuele

Catania, 95124, Italy

Location

Università degli Studi "G. D'Annunzio"

Chieti Scalo, 66013, Italy

Location

Azienda Ospedaliera "Madonna delle Grazie"

Matera, 75100, Italy

Location

Ospedale San Paolo

Milan, 20142, Italy

Location

Ospedale San Carlo Borromeo

Milan, 20153, Italy

Location

Presidio Ospedaliero San Lorenzo

Palermo, 90146, Italy

Location

Presidio Ospedaliero di Portogruaro

Portogruaro (VE), 30026, Italy

Location

Azienda Policlinico Universitario a Gestione Diret

Udine, 33100, Italy

Location

Unknown Facility

's-Hertogenbosch, 5216 GC, Netherlands

Location

Maxima Medisch Centrum

Eindhoven, 5631 BM, Netherlands

Location

H. Elvas

Elvas, 7350-954, Netherlands

Location

Unknown Facility

Hilversum, 1214 JR, Netherlands

Location

Unknown Facility

Lieshout, 5737 CB, Netherlands

Location

Unknown Facility

Waalwijk, 5144 CB, Netherlands

Location

H. Almada

Almada Almada, 2801-951, Portugal

Location

Hospital Fernando da Fonseca

Amadora Amadora, 2720-276, Portugal

Location

Hospital de. S. Marta

Lisboa Lisboa, 1169-024, Portugal

Location

Zentrum Oberdorf

Affoltern am Albis, 8910, Switzerland

Location

Unknown Facility

Bellinzona, 6500, Switzerland

Location

Unknown Facility

Gland, 1196, Switzerland

Location

Unknown Facility

Petit Lancy, 1213, Switzerland

Location

Praxis Dreispitz

Zurich, 8050, Switzerland

Location

The Atherstone Surgery

Atherstone, CV9 1EU, United Kingdom

Location

The Medical Centre

Birmingham, B37 7TR, United Kingdom

Location

Waterloo Medical Centre

Blackpool, FY4 3AD, United Kingdom

Location

Rowden Surgery

Chippenham, SN15 2SB, United Kingdom

Location

The Gables Medical Centre

Coventry, CV6 4DD, United Kingdom

Location

Bridge Medical Centre

Crawley, RH10 1LL, United Kingdom

Location

Homefield Surgery

Exeter, EX1 2QS, United Kingdom

Location

Woodside Health Centre

Glasgow, G20 7LR, United Kingdom

Location

Castle Milk Health Centre

Glasgow, G45 9 AW, United Kingdom

Location

Division of Cardiovascular and Endocrine Sciences

Manchester, M13 9NT, United Kingdom

Location

University of Manchester

Manchester, M13 9WL, United Kingdom

Location

Oakside Surgery

Plymouth, PL5 3PY, United Kingdom

Location

Norwood Medical Centre

Sheffield, S5 7HD, United Kingdom

Location

Lovemead Group Practice

Trowbridge, BA14 7EG, United Kingdom

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Olmesartan Medoxomil; Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dihydropyridines; Pyridines

Results Point of Contact

• Title: Sr. Director, Regulatory Operations
• Organization: Daiichi Sankyo Pharma Development

hmkessler@dsi.com

732-590-5032

Study Officials

• Anthony Heagerty, MD

  University of Manchester, Dept. of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 5, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 10, 2010
• Results First Posted: November 10, 2010

Record last verified: 2010-11

Locations

GB (14); NL (6); DE (14); AU (6); FR (14); BE (4); PT (3); IT (13); CH (5)