Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose

NCT00034840 | Completed Phase 4

• 1 other identifier: 502.327
• Study Type: interventional
• Target: 490
• Locations: 2 countries
• Sites: 35

Brief Summary

The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.

Conditions

Hypertension

Keywords

hypertension; telmisartan; valsartan; boehringer

Outcome Measures

Primary Outcomes (2)

• Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose

  after 6 to 8 weeks

• Change in the mean DBP during the last 6 hours of the 24-hour dosing interval, as measured by ABPM after an active dose of study medication

  after 6 to 8 weeks

Secondary Outcomes (8)

• Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose

  after 6 to 8 weeks

• Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment

  after 6 to 8 weeks

• Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose

  8 weeks

• Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose

  8 weeks

• Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose

  8 weeks

Interventions

telmisartan, valsartan DRUG

Eligibility Criteria

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

You may qualify if:

• \. Mild-to-moderate hypertension defined as a baseline mean seated DBP of greater than or equal to 95 mm Hg and less than or equal to 109 mm Hg and a baseline 24-hour ABPM mean DBP of greater than or equal to 85 mm Hg.

You may not qualify if:

• Pre-menopausal women (last menstruation = 1 year prior to signing informed consent) who:
• Are not surgically sterile.
• Are nursing.
• Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives. No exceptions will be made.
• Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
• Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
• Known or suspected secondary hypertension (i.e., pheochromocytoma).
• Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
• SGPT (ALT) or SGOT (AST) \> 2 times the upper limit of normal range.
• Serum creatinine \> 2.3 mg/dL (or \> 203 µmol/l).
• Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
• Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
• Uncorrected volume depletion.
• Primary aldosteronism.
• Hereditary fructose intolerance.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• GlaxoSmithKline: collaborator
• Bayer: collaborator

Study Sites (35)

Memorial Research Medical Clinic

Long Beach, California, 90806, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Orange County Research Center

Orange, California, 92868, United States

Location

University of Conn. Health Services Center, Hypertension and Vascular Disease

Farmington, Connecticut, 06030, United States

Location

Alan Graff

Fort Lauderdale, Florida, 33308, United States

Location

Greater Ft. Lauderdale Heart Group Research

Fort Lauderdale, Florida, 33308, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32806, United States

Location

So. Clinical Research and Management, Inc.

Augusta, Georgia, 30904, United States

Location

Rush Presbyterian/St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Maryland/Nephrology Clinical Research Unit

Baltimore, Maryland, 21201, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Oklahoma Cardiovascular and Hypertension Center

Oklahoma City, Oklahoma, 73132, United States

Location

Michael A. Azorr, M.D.

Portland, Oregon, 97232, United States

Location

Harleysville Medical Associates

Harleysville, Pennsylvania, 19438, United States

Location

Trinity Hypertension Research Institute/Punzi Medical Center

Carrollton, Texas, 75006, United States

Location

UW Health/Physicians Plus Center for Clinical Trials

Madison, Wisconsin, 53715, United States

Location

Heart Health Institute

Calgary, Alberta, T2E 7C5, Canada

Location

Dr. Dennis O'Keefe

Mount Pearl, Newfoundland and Labrador, A1N 2C3, Canada

Location

Dr. William Booth

Antigonish, Nova Scotia, B2G 2C2, Canada

Location

MSHJ Research Assoc.

Halifax, Nova Scotia, B3K 5R3, Canada

Location

Dr. Joseph Berlingieri

Burlington, Ontario, L7R 2H3, Canada

Location

Dr. William Mahoney

Corunna, Ontario, N0N 1G0, Canada

Location

BBM Clinical Research Ltd.

Courtice, Ontario, L1E 3C3, Canada

Location

Dr. Richard Tytus

Hamilton, Ontario, L8M 1K7, Canada

Location

Total Concept Health Care

Kitchener, Ontario, N2C 2N9, Canada

Location

Centre for Activity and Aging

London, Ontario, N6G 2M3, Canada

Location

Dr. Martyn Chilvers

Sarnia, Ontario, N7T 4X3, Canada

Location

Sunnybrook & Women's College Health Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Theradev Clinical Research, Inc.

Granby, Quebec, J2G 8Z9, Canada

Location

Invascor, Longueuil

Longueuil, Quebec, J4N 1E1, Canada

Location

Hotel Dieu de St-Jerome

Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

Centre de Cardiologie

Saint-Lambert, Quebec, J4P 2H4, Canada

Location

Centre Hospital Quebec - PAC CHUL Unite de Recherche

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Q&T Research

Sherbrooke, Quebec, J1H 4J6, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: October 1, 2001
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

CA (19); US (16)