Clinical trial NCT00240448: A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients
Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Forced-titration, Comparison of MICARDIS® HCT (Telmisartan 80 mg / Hydrochlorothiazide 25 mg) Versus DIOVAN® HCT (Valsartan 160 mg / Hydrochlorothiazide 25 mg) Using Seated Trough Cuff Blood Pressure in Patients With Stage 1 and Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 1109
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 objective of this study is to compare the effectiveness of telmisartan 80 mg/hydrochlorothiazide 25 mg \[Micardis HCT\] to valsartan 160 mg/hydrochlorothiazide 25 mg \[Diovan HCT\] and placebo in the treatment of Stage 1 and Stage 2 hypertension.


Eligibility criteria: Inclusion criteria

1. Ability to provide written informed consent.
2. Age 18 years or older.
3. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion).
4. Seated cuff DBP of 95 mmHg at Visit 2 (baseline).

Exclusion criteria

1. Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:

   * Are not surgically sterile and/or
   * Are nursing or pregnant
   * Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of \> 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).
2. Known or suspected secondary hypertension.
3. Mean seated SBP \>= 180 mmHg or mean seated DBP \>= 120 mmHg during any clinic visit prior to randomization.
4. 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, or
   * Serum creatinine \> 3.0 mg/dL or creatinine clearance \< 0.6 ml/sec.
5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
6. Clinically relevant hypokalemia or hyperkalemia.
7. Uncorrected volume depletion.
8. Uncorrected sodium depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency.
12. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
13. History of drug or alcohol dependency within six months prior to start of run-in period.
14. Chronic administration of any medications known to affect blood pressure, etc.
15. Any investigational drug therapy within one month of start of run-in period.
16. known hypersensitivity to any component of the formulation study drugs (telmisartan, valsartan, HCT).
17. Contra-indication to a placebo run-in period (e.g. stroke within the past six months, MI, cardia surgery, PTCA or angina within the past three months prior to the start of run-in period.
18. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan, valsartan, or HCT.
19. Night shift workers.
20. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
21. NYHA functional class CHF III-IV.
22. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
23. Patients whose diabetes has been unstable and uncontrolled for at least the past 3 months as defined by a HbA1c \>/= 10%.
24. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCT).
25. History of non-compliance with prescribed medication or protocol procedures.

Primary outcomes:
measure: Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period
Secondary outcomes:
measure: Percentage of responders based on change from baseline in cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Sctoosdale
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Bentonville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arkansas
city: Carlisle
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arkansas
city: Concord
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: Memorial Research Medical Clinic
state: California
city: Orange
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Riverside
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Roseville
country: United States
facility: Clinical Trials Research
state: California
city: Sacramento
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: San Leandro
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Santa Ana
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Sepulveda
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Spring Valley
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Torrance
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Boulder
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: Bridgeport
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Connecticut
city: Farmington
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Connecticut
city: Trumbull
country: United States
facility: Clinical Research Consultants, Inc.
state: Connecticut
city: Waterbury
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Delaware
city: Coral Gables
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Ft. Myers
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Holiday
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Christopher Chappel, MD
state: Florida
city: Largo
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Palm Harbor
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Panama City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Attention: Larry I. Gilderman, D.O.
state: Florida
city: Pembroke Pines
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Conyers
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Cardiology
state: Idaho
city: Chicago
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: Herron Medical Center, Ltd.
state: Illinois
city: Orland Park
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Peoria
country: United States
facility: N Touch Research
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research Inc.
state: Indiana
city: Waterloo
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Iowa
city: Shawnee
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Attn:William Smith
state: Louisiana
city: Baltimore
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Maryland
city: Brookline
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Waltham
country: United States
facility: Waltham Hospital
state: Massachusetts
city: Troy
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Michigan
city: Brooklyn Center
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Minnesota
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Jackson
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Missouri
city: Camden
country: United States
facility: Department of Medicine
state: New Jersey
city: Cherry Hill
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Kingston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Northport
country: United States
facility: Northport VAMC - Medical Service (111)
state: New York
city: Rochester
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Scarsdale
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Burlington
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cary
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Stateville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Reseach
state: Ohio
city: Columbus
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Mansfield
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Ohio
city: Mogadore
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Collegeville
country: United States
facility: Bock Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pottstown
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Carrollton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: McKinney
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Utah
city: Falls Church
country: United States
facility: Clinical Research Center of N. VA
state: Virginia
city: Lacey
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Lakewood
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Madison
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: