Clinical trial NCT00034840: Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose
Official title: A Prospective, Randomized, Double-Blind, Forced Titration Trial to Compare the Efficacy of MICARDIS® (Telmisartan 80 mg p.o. Once Daily) and Diovan® (Valsartan 160 mg p.o. Once Daily) Using Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Hypertension After Missing One Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
telmisartan
valsartan
boehringer
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
name: Bayer
First posted: 2002-05-03
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. 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.
2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
3. Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
4. Known or suspected secondary hypertension (i.e., pheochromocytoma).
5. 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).
6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
7. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
8. Uncorrected volume depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders.
12. Congestive heart failure (NYHA functional class CHF III-IV).
13. Unstable angina within the past three months prior to signing the informed consent form.
14. Stroke within the past six months prior to signing the informed consent form.
15. Myocardial infarction or cardiac surgery within the past three months prior to signing the informed consent form.
16. PTCA (percutaneous transluminal coronary revascularization) within the past three months prior to signing the informed consent form.
17. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
18. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
19. Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C =10%.
20. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
21. History of drug or alcohol dependency within 6 months prior to signing the informed consent form.
22. Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
23. Any investigational therapy within one month of signing the informed consent form.
24. Known hypersensitivity to any component of the formulations.
25. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
26. Inability to comply with the protocol.

Primary outcomes:
measure: Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose
timeFrame: after 6 to 8 weeks
measure: 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
timeFrame: after 6 to 8 weeks
Secondary outcomes:
measure: Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose
timeFrame: after 6 to 8 weeks
measure: Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment
timeFrame: after 6 to 8 weeks
measure: Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose
timeFrame: 8 weeks
measure: Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose
timeFrame: 8 weeks
measure: Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose
timeFrame: 8 weeks
measure: Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after an active dose
timeFrame: 8 weeks
measure: Responder rates based on ABPM
timeFrame: after 6 to 8 weeks
measure: Responder rates based on in-clinic trough cuff blood pressures
timeFrame: after 6 to 8 weeks
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Memorial Research Medical Clinic
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Orange
country: United States
facility: Orange County Research Center
state: California
city: Farmington
country: United States
facility: University of Conn. Health Services Center, Hypertension and Vascular Disease
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Alan Graff
state: Florida
city: Ft. Lauderdale
country: United States
facility: Greater Ft. Lauderdale Heart Group Research
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Augusta
country: United States
facility: So. Clinical Research and Management, Inc.
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian/St. Luke's Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland/Nephrology Clinical Research Unit
state: Maryland
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular and Hypertension Center
state: Oklahoma
city: Portland
country: United States
facility: Michael A. Azorr, M.D.
state: Oregon
city: Harleysville
country: United States
facility: Harleysville Medical Associates
state: Pennsylvania
city: Carrollton
country: United States
facility: Trinity Hypertension Research Institute/Punzi Medical Center
state: Texas
city: Madison
country: United States
facility: UW Health/Physicians Plus Center for Clinical Trials
state: Wisconsin
city: Calgary
country: Canada
facility: Heart Health Institute
state: Alberta
city: Mount Pearl
country: Canada
facility: Dr. Dennis O'Keefe
state: Newfoundland and Labrador
city: Antigonish
country: Canada
facility: Dr. William Booth
state: Nova Scotia
city: Halifax
country: Canada
facility: MSHJ Research Assoc.
state: Nova Scotia
city: Burlington
country: Canada
facility: Dr. Joseph Berlingieri
state: Ontario
city: Corunna
country: Canada
facility: Dr. William Mahoney
state: Ontario
city: Courtice
country: Canada
facility: BBM Clinical Research Ltd.
state: Ontario
city: Hamilton
country: Canada
facility: Dr. Richard Tytus
state: Ontario
city: Kitchener
country: Canada
facility: Total Concept Health Care
state: Ontario
city: London
country: Canada
facility: Centre for Activity and Aging
state: Ontario
city: Sarnia
country: Canada
facility: Dr. Martyn Chilvers
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Centre
state: Ontario
city: Granby
country: Canada
facility: Theradev Clinical Research, Inc.
state: Quebec
city: Longueuil
country: Canada
facility: Invascor, Longueuil
state: Quebec
city: Saint Jerome
country: Canada
facility: Hotel Dieu de St-Jerome
state: Quebec
city: Saint Lambert
country: Canada
facility: Centre de Cardiologie
state: Quebec
city: Sainte-Foy
country: Canada
facility: Centre Hospital Quebec - PAC CHUL Unite de Recherche
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: