Clinical trial NCT00168779: Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension
Official title: A Randomized, Double-blind, Placebo-controlled, Forced-titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg Taken Orally for Eight Weeks in Patients With Stage 1 or Stage 2 Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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:

   1. are not surgically sterile and/or
   2. are nursing or pregnant
   3. 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:

   1. SGPT (ALT) or SGOT (AST) \> 2 times the upper limit of normal range, or
   2. 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, cholestatis or moderate to severe hepatic in sufficiency.
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, exc

Primary outcomes:
measure: Mean seated trough cuff DBP and SBP
timeFrame: after 8 week
Secondary outcomes:
measure: The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements
timeFrame: after 8 week
measure: The percentage of patients with uncontrolled hypertension
timeFrame: after 8 weeks
measure: Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points
timeFrame: after 8 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: 502.476.074 Boehringer Ingelheim Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: 502.476.059 Boehringer Ingelheim Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: 502.476.071 Boehringer Ingelheim Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: 502.476.079 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 502.476.014 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 502.476.031 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 502.476.110 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 502.476.037 Boehringer Ingelheim Investigational Site
state: Alabama
city: Glendale
country: United States
facility: 502.476.061 Boehringer Ingelheim Investigational Site
state: Arizona
city: Carlisle
country: United States
facility: 502.476.066 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Buena Park
country: United States
facility: 502.476.067 Boehringer Ingelheim Investigational Site
state: California
city: Encinitas
country: United States
facility: 502.476.086 Boehringer Ingelheim Investigational Site
state: California
city: Greenbrae
country: United States
facility: 502.476.124 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 502.476.005 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 502.476.024 Boehringer Ingelheim Investigational Site
state: California
city: Redondo Beach
country: United States
facility: 502.476.029 Boehringer Ingelheim Investigational Site
state: California
city: Riverside
country: United States
facility: 502.476.048 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 502.476.073 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 502.476.087 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 502.476.111 Boehringer Ingelheim Investigational Site
state: California
city: Santa Ana
country: United States
facility: 502.476.050 Boehringer Ingelheim Investigational Site
state: California
city: Spring Valley
country: United States
facility: 502.476.026 Boehringer Ingelheim Investigational Site
state: California
city: Tulsa
country: United States
facility: 502.476.033 Boehringer Ingelheim Investigational Site
state: California
city: Boulder
country: United States
facility: 502.476.019 Boehringer Ingelheim Investigational Site
state: Colorado
city: Highlands Ranch
country: United States
facility: 502.476.101 Boehringer Ingelheim Investigational Site
state: Colorado
city: Farmington
country: United States
facility: 502.476.053 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Newark
country: United States
facility: 502.476.032 Boehringer Ingelheim Investigational Site
state: Delaware
city: Coral Gables
country: United States
facility: 502.476.041 Boehringer Ingelheim Investigational Site
state: Florida
city: DeLand
country: United States
facility: 502.476.108 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: 502.476.015 Boehringer Ingelheim Investigational Site
state: Florida
city: Hollywood
country: United States
facility: 502.476.044 Boehringer Ingelheim Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: 502.476.058 FPA Clinical Research
state: Florida
city: Largo
country: United States
facility: 502.476.052 Boehringer Ingelheim Investigational Site
state: Florida
city: Melbourne
country: United States
facility: 502.476.080 Boehringer Ingelheim Investigational Site
state: Florida
city: Panama City
country: United States
facility: 502.476.021 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 502.476.012 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 502.476.036 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 502.476.065 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 502.476.022 Boehringer Ingelheim Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: 502.476.049 Boehringer Ingelheim Investigational Site
state: Georgia
city: Conyers
country: United States
facility: 502.476.008 Boehringer Ingelheim Investigational Site
state: Georgia
city: Decatur
country: United States
facility: 502.476.075 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 502.476.018 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 502.476.047 Boehringer Ingelheim Investigational Site
state: Illinois
city: Peoria
country: United States
facility: 502.476.004 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evansville
country: United States
facility: 502.476.062 Boehringer Ingelheim Investigational Site
state: Indiana
city: Evansville
country: United States
facility: 502.476.063 Boehringer Ingelheim Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: 502.476.051 Boehringer Ingelheim Investigational Site
state: Indiana
city: South Bend
country: United States
facility: 502.476.084 Boehringer Ingelheim Investigational Site
state: Indiana
city: South Bend
country: United States
facility: 502.476.090 Boehringer Ingelheim Investigational Site
state: Indiana
city: Newton
country: United States
facility: 502.476.100 Boehringer Ingelheim Investigational Site
state: Kansas
city: Wichita
country: United States
facility: 502.476.003 Boehringer Ingelheim Investigational Site
state: Kansas
city: Wichita
country: United States
facility: 502.476.038 Boehringer Ingelheim Investigational Site
state: Kansas
city: Louisville
country: United States
facility: 502.476.002 Boehringer Ingelheim Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: 502.476.116 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Oxon Hill
country: United States
facility: 502.476.035 Boehringer Ingelheim Investigational Site
state: Maryland
city: Troy
country: United States
facility: 502.476.010 Boehringer Ingelheim Investigational Site
state: Michigan
city: Brooklyn Center
country: United States
facility: 502.476.028 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Edina
country: United States
facility: 502.476.057 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: 502.476.055 Boehringer Ingelheim Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: 502.476.114 Boehringer Ingelheim Investigational Site
state: Missouri
city: Omaha
country: United States
facility: 502.476.112 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: 502.476.126 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: 502.476.125 Boehringer Ingelheim Investigational Site
state: Nevada
city: Berlin
country: United States
facility: 502.476.120 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Ship Bottom
country: United States
facility: 502.476.088 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Turnersville
country: United States
facility: 502.476.089 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: 502.476.068 Boehringer Ingelheim Investigational Site
state: New York
city: Hamburg
country: United States
facility: 502.476.122 Boehringer Ingelheim Investigational Site
state: New York
city: Northport
country: United States
facility: 502.476.020 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 502.476.025 Boehringer Ingelheim Investigational Site
state: New York
city: Williamsville
country: United States
facility: 502.476.091 Boehringer Ingelheim Investigational Site
state: New York
city: Burlington
country: United States
facility: 502.476.046 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: 502.476.083 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: 502.476.042 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: 502.476.095 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 502.476.027 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 502.476.034 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 502.476.060 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 502.476.016 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 502.476.023 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 502.476.128 Boehringer Ingelheim Investigational Site
state: Ohio
city: Kettering
country: United States
facility: 502.476.064 Boehringer Ingelheim Investigational Site
state: Ohio
city: Olmstead Township
country: United States
facility: 502.476.103 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 502.476.007 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: 502.476.113 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: 502.476.030 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: 502.476.104 Boehringer Ingelheim Investigational Site
state: Oregon
city: Erie
country: United States
facility: 502.476.109 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Harleysville
country: United States
facility: 502.476.094 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Penndel
country: United States
facility: 502.476.121 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 502.476.072 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Springfield
country: United States
facility: 502.476.076 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: 502.476.013 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Cordova
country: United States
facility: 502.476.085 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: 502.476.096 Boehringer Ingelheim Investigational Site
state: Tennessee
city: New Tazewell
country: United States
facility: 502.476.081 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Selmer
country: United States
facility: 502.476.082 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Carrollton
country: United States
facility: 502.476.039 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 502.476.056 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 502.476.069 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 502.476.107 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 502.476.070 Boehringer Ingelheim Investigational Site
state: Texas
city: Bountiful
country: United States
facility: 502.476.001 Boehringer Ingelheim Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: 502.476.006 Boehringer Ingelheim Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: 502.476.017 Boehringer Ingelheim Investigational Site
state: Utah
city: Sandy
country: United States
facility: 502.476.097 Boehringer Ingelheim Investigational Site
state: Utah
city: Sandy
country: United States
facility: 502.476.098 Boehringer Ingelheim Investigational Site
state: Utah
city: Falls Church
country: United States
facility: 502.476.011 Boehringer Ingelheim Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: 502.476.093 Boehringer Ingelheim Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: 502.476.078 Boehringer Ingelheim Investigational Site
state: Washington
city: Menomonee Falls
country: United States
facility: 502.476.106 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: 502.476.105 Boehringer Ingelheim Investigational Site
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: