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
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00168779
Collaborator
(none)
1,185
113
10
10.5
1.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
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 Start Date
:
Sep 1, 2005
Actual Primary Completion Date
:
Jul 1, 2006
Actual Study Completion Date
:
Jul 1, 2006
Outcome Measures
Primary Outcome Measures
- Mean seated trough cuff DBP and SBP [after 8 week]
Secondary Outcome Measures
- The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements [after 8 week]
- The percentage of patients with uncontrolled hypertension [after 8 weeks]
- Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points [after 8 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Ability to provide written informed consent.
-
Age 18 years or older
-
Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
-
Seated cuff DBP of ? 95 mmHg at Visit 2 (baseline)
Exclusion Criteria:
-
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).
-
Known or suspected secondary hypertension.
-
Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization.
-
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.
-
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
-
Clinically relevant hypokalemia or hyperkalemia.
-
Uncorrected volume depletion.
-
Uncorrected sodium depletion.
-
Primary aldosteronism.
-
Hereditary fructose intolerance.
-
Biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
-
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
-
History of drug or alcohol dependency within six months prior to start of run-in period.
-
Chronic administration of any medications known to affect blood pressure, exc
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 502.476.074 Boehringer Ingelheim Investigational Site | Athens | Alabama | United States | |
| 2 | 502.476.059 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 3 | 502.476.071 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 4 | 502.476.079 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | United States | |
| 5 | 502.476.014 Boehringer Ingelheim Investigational Site | Huntsville | Alabama | United States | |
| 6 | 502.476.031 Boehringer Ingelheim Investigational Site | Huntsville | Alabama | United States | |
| 7 | 502.476.110 Boehringer Ingelheim Investigational Site | Huntsville | Alabama | United States | |
| 8 | 502.476.037 Boehringer Ingelheim Investigational Site | Mobile | Alabama | United States | |
| 9 | 502.476.061 Boehringer Ingelheim Investigational Site | Glendale | Arizona | United States | |
| 10 | 502.476.066 Boehringer Ingelheim Investigational Site | Carlisle | Arkansas | United States | |
| 11 | 502.476.067 Boehringer Ingelheim Investigational Site | Buena Park | California | United States | |
| 12 | 502.476.086 Boehringer Ingelheim Investigational Site | Encinitas | California | United States | |
| 13 | 502.476.124 Boehringer Ingelheim Investigational Site | Greenbrae | California | United States | |
| 14 | 502.476.005 Boehringer Ingelheim Investigational Site | Long Beach | California | United States | |
| 15 | 502.476.024 Boehringer Ingelheim Investigational Site | Los Angeles | California | United States | |
| 16 | 502.476.029 Boehringer Ingelheim Investigational Site | Redondo Beach | California | United States | |
| 17 | 502.476.048 Boehringer Ingelheim Investigational Site | Riverside | California | United States | |
| 18 | 502.476.073 Boehringer Ingelheim Investigational Site | Sacramento | California | United States | |
| 19 | 502.476.087 Boehringer Ingelheim Investigational Site | San Diego | California | United States | |
| 20 | 502.476.111 Boehringer Ingelheim Investigational Site | San Francisco | California | United States | |
| 21 | 502.476.050 Boehringer Ingelheim Investigational Site | Santa Ana | California | United States | |
| 22 | 502.476.026 Boehringer Ingelheim Investigational Site | Spring Valley | California | United States | |
| 23 | 502.476.033 Boehringer Ingelheim Investigational Site | Tulsa | California | United States | |
| 24 | 502.476.019 Boehringer Ingelheim Investigational Site | Boulder | Colorado | United States | |
| 25 | 502.476.101 Boehringer Ingelheim Investigational Site | Highlands Ranch | Colorado | United States | |
| 26 | 502.476.053 Boehringer Ingelheim Investigational Site | Farmington | Connecticut | United States | |
| 27 | 502.476.032 Boehringer Ingelheim Investigational Site | Newark | Delaware | United States | |
| 28 | 502.476.041 Boehringer Ingelheim Investigational Site | Coral Gables | Florida | United States | |
| 29 | 502.476.108 Boehringer Ingelheim Investigational Site | DeLand | Florida | United States | |
| 30 | 502.476.015 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida | United States | |
| 31 | 502.476.044 Boehringer Ingelheim Investigational Site | Hollywood | Florida | United States | |
| 32 | 502.476.058 FPA Clinical Research | Kissimmee | Florida | United States | |
| 33 | 502.476.052 Boehringer Ingelheim Investigational Site | Largo | Florida | United States | |
| 34 | 502.476.080 Boehringer Ingelheim Investigational Site | Melbourne | Florida | United States | |
| 35 | 502.476.021 Boehringer Ingelheim Investigational Site | Panama City | Florida | United States | |
| 36 | 502.476.012 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 37 | 502.476.036 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 38 | 502.476.065 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida | United States | |
| 39 | 502.476.022 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 40 | 502.476.049 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | United States | |
| 41 | 502.476.008 Boehringer Ingelheim Investigational Site | Conyers | Georgia | United States | |
| 42 | 502.476.075 Boehringer Ingelheim Investigational Site | Decatur | Georgia | United States | |
| 43 | 502.476.018 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 44 | 502.476.047 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States | |
| 45 | 502.476.004 Boehringer Ingelheim Investigational Site | Peoria | Illinois | United States | |
| 46 | 502.476.062 Boehringer Ingelheim Investigational Site | Evansville | Indiana | United States | |
| 47 | 502.476.063 Boehringer Ingelheim Investigational Site | Evansville | Indiana | United States | |
| 48 | 502.476.051 Boehringer Ingelheim Investigational Site | Indianapolis | Indiana | United States | |
| 49 | 502.476.084 Boehringer Ingelheim Investigational Site | South Bend | Indiana | United States | |
| 50 | 502.476.090 Boehringer Ingelheim Investigational Site | South Bend | Indiana | United States | |
| 51 | 502.476.100 Boehringer Ingelheim Investigational Site | Newton | Kansas | United States | |
| 52 | 502.476.003 Boehringer Ingelheim Investigational Site | Wichita | Kansas | United States | |
| 53 | 502.476.038 Boehringer Ingelheim Investigational Site | Wichita | Kansas | United States | |
| 54 | 502.476.002 Boehringer Ingelheim Investigational Site | Louisville | Kentucky | United States | |
| 55 | 502.476.116 Boehringer Ingelheim Investigational Site | New Orleans | Louisiana | United States | |
| 56 | 502.476.035 Boehringer Ingelheim Investigational Site | Oxon Hill | Maryland | United States | |
| 57 | 502.476.010 Boehringer Ingelheim Investigational Site | Troy | Michigan | United States | |
| 58 | 502.476.028 Boehringer Ingelheim Investigational Site | Brooklyn Center | Minnesota | United States | |
| 59 | 502.476.057 Boehringer Ingelheim Investigational Site | Edina | Minnesota | United States | |
| 60 | 502.476.055 Boehringer Ingelheim Investigational Site | Kansas City | Missouri | United States | |
| 61 | 502.476.114 Boehringer Ingelheim Investigational Site | Saint Louis | Missouri | United States | |
| 62 | 502.476.112 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States | |
| 63 | 502.476.126 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | United States | |
| 64 | 502.476.125 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada | United States | |
| 65 | 502.476.120 Boehringer Ingelheim Investigational Site | Berlin | New Jersey | United States | |
| 66 | 502.476.088 Boehringer Ingelheim Investigational Site | Ship Bottom | New Jersey | United States | |
| 67 | 502.476.089 Boehringer Ingelheim Investigational Site | Turnersville | New Jersey | United States | |
| 68 | 502.476.068 Boehringer Ingelheim Investigational Site | Brooklyn | New York | United States | |
| 69 | 502.476.122 Boehringer Ingelheim Investigational Site | Hamburg | New York | United States | |
| 70 | 502.476.020 Boehringer Ingelheim Investigational Site | Northport | New York | United States | |
| 71 | 502.476.025 Boehringer Ingelheim Investigational Site | Rochester | New York | United States | |
| 72 | 502.476.091 Boehringer Ingelheim Investigational Site | Williamsville | New York | United States | |
| 73 | 502.476.046 Boehringer Ingelheim Investigational Site | Burlington | North Carolina | United States | |
| 74 | 502.476.083 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | United States | |
| 75 | 502.476.042 Boehringer Ingelheim Investigational Site | Raleigh | North Carolina | United States | |
| 76 | 502.476.095 Boehringer Ingelheim Investigational Site | Salisbury | North Carolina | United States | |
| 77 | 502.476.027 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | United States | |
| 78 | 502.476.034 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 79 | 502.476.060 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States | |
| 80 | 502.476.016 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 81 | 502.476.023 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 82 | 502.476.128 Boehringer Ingelheim Investigational Site | Columbus | Ohio | United States | |
| 83 | 502.476.064 Boehringer Ingelheim Investigational Site | Kettering | Ohio | United States | |
| 84 | 502.476.103 Boehringer Ingelheim Investigational Site | Olmstead Township | Ohio | United States | |
| 85 | 502.476.007 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States | |
| 86 | 502.476.113 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | United States | |
| 87 | 502.476.030 Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma | United States | |
| 88 | 502.476.104 Boehringer Ingelheim Investigational Site | Portland | Oregon | United States | |
| 89 | 502.476.109 Boehringer Ingelheim Investigational Site | Erie | Pennsylvania | United States | |
| 90 | 502.476.094 Boehringer Ingelheim Investigational Site | Harleysville | Pennsylvania | United States | |
| 91 | 502.476.121 Boehringer Ingelheim Investigational Site | Penndel | Pennsylvania | United States | |
| 92 | 502.476.072 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States | |
| 93 | 502.476.076 Boehringer Ingelheim Investigational Site | Springfield | Pennsylvania | United States | |
| 94 | 502.476.013 Boehringer Ingelheim Investigational Site | East Providence | Rhode Island | United States | |
| 95 | 502.476.085 Boehringer Ingelheim Investigational Site | Cordova | Tennessee | United States | |
| 96 | 502.476.096 Boehringer Ingelheim Investigational Site | Jackson | Tennessee | United States | |
| 97 | 502.476.081 Boehringer Ingelheim Investigational Site | New Tazewell | Tennessee | United States | |
| 98 | 502.476.082 Boehringer Ingelheim Investigational Site | Selmer | Tennessee | United States | |
| 99 | 502.476.039 Boehringer Ingelheim Investigational Site | Carrollton | Texas | United States | |
| 100 | 502.476.056 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 101 | 502.476.069 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 102 | 502.476.107 Boehringer Ingelheim Investigational Site | Dallas | Texas | United States | |
| 103 | 502.476.070 Boehringer Ingelheim Investigational Site | Killeen | Texas | United States | |
| 104 | 502.476.001 Boehringer Ingelheim Investigational Site | Bountiful | Utah | United States | |
| 105 | 502.476.006 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States | |
| 106 | 502.476.017 Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States | |
| 107 | 502.476.097 Boehringer Ingelheim Investigational Site | Sandy | Utah | United States | |
| 108 | 502.476.098 Boehringer Ingelheim Investigational Site | Sandy | Utah | United States | |
| 109 | 502.476.011 Boehringer Ingelheim Investigational Site | Falls Church | Virginia | United States | |
| 110 | 502.476.093 Boehringer Ingelheim Investigational Site | Norfolk | Virginia | United States | |
| 111 | 502.476.078 Boehringer Ingelheim Investigational Site | Tacoma | Washington | United States | |
| 112 | 502.476.106 Boehringer Ingelheim Investigational Site | Menomonee Falls | Wisconsin | United States | |
| 113 | 502.476.105 Boehringer Ingelheim Investigational Site | Milwaukee | Wisconsin | United States |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00168779
Other Study ID Numbers:
- 502.476
First Posted:
Sep 15, 2005
Last Update Posted:
Dec 28, 2017
Last Verified:
Dec 1, 2017