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



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/30/2017
Start Date:September 2005
End Date:July 2006

Use our guide to learn which trials are right for you!

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.

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.


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
We found this trial at
93
sites
222 Broadway
Kissimmee, Florida 34741
2557
mi
from 98109
Kissimmee, FL
Click here to add this to my saved trials
2017
mi
from 98109
Athens, AL
Click here to add this to my saved trials
2178
mi
from 98109
Atlanta, GA
Click here to add this to my saved trials
2405
mi
from 98109
Berlin, NJ
Click here to add this to my saved trials
2079
mi
from 98109
Birmingham, AL
Click here to add this to my saved trials
996
mi
from 98109
Boulder, CO
Click here to add this to my saved trials
695
mi
from 98109
Bountiful, UT
Click here to add this to my saved trials
2403
mi
from 98109
Brooklyn, NY
Click here to add this to my saved trials
1386
mi
from 98109
Brooklyn Center, MN
Click here to add this to my saved trials
977
mi
from 98109
Buena Park, CA
Click here to add this to my saved trials
2312
mi
from 98109
Burlington, NC
Click here to add this to my saved trials
1804
mi
from 98109
Carlisle, AR
Click here to add this to my saved trials
1667
mi
from 98109
Carrollton, TX
Click here to add this to my saved trials
Charlotte, North Carolina
2281
mi
from 98109
Charlotte, NC
Click here to add this to my saved trials
1733
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
1967
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
2008
mi
from 98109
Columbus, OH
Click here to add this to my saved trials
2199
mi
from 98109
Conyers, GA
Click here to add this to my saved trials
2730
mi
from 98109
Coral Gables, FL
Click here to add this to my saved trials
1876
mi
from 98109
Cordova, TN
Click here to add this to my saved trials
1681
mi
from 98109
Dallas, TX
Click here to add this to my saved trials
2182
mi
from 98109
Decatur, GA
Click here to add this to my saved trials
2527
mi
from 98109
Deland, FL
Click here to add this to my saved trials
2487
mi
from 98109
East Providence, RI
Click here to add this to my saved trials
1389
mi
from 98109
Edina, MN
Click here to add this to my saved trials
1041
mi
from 98109
Encinitas, CA
Click here to add this to my saved trials
2076
mi
from 98109
Erie, PA
Click here to add this to my saved trials
1865
mi
from 98109
Evansville, IN
Click here to add this to my saved trials
2316
mi
from 98109
Falls Church, VA
Click here to add this to my saved trials
2425
mi
from 98109
Farmington, CT
Click here to add this to my saved trials
2717
mi
from 98109
Fort Lauderdale, FL
Click here to add this to my saved trials
1107
mi
from 98109
Glendale, AZ
Click here to add this to my saved trials
669
mi
from 98109
Greenbrae, CA
Click here to add this to my saved trials
2402
mi
from 98109
Hamburg, NY
Click here to add this to my saved trials
2351
mi
from 98109
Harleysville, PA
Click here to add this to my saved trials
1029
mi
from 98109
Highlands Ranch, CO
Click here to add this to my saved trials
2721
mi
from 98109
Hollywood, FL
Click here to add this to my saved trials
2038
mi
from 98109
Huntsville, AL
Click here to add this to my saved trials
1868
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
1900
mi
from 98109
Jackson, TN
Click here to add this to my saved trials
1503
mi
from 98109
Kansas City, MO
Click here to add this to my saved trials
1963
mi
from 98109
Kettering, OH
Click here to add this to my saved trials
1727
mi
from 98109
Killeen, TX
Click here to add this to my saved trials
2513
mi
from 98109
Largo, FL
Click here to add this to my saved trials
873
mi
from 98109
Las Vegas, NV
Click here to add this to my saved trials
982
mi
from 98109
Long Beach, CA
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
1938
mi
from 98109
Louisville, KY
Click here to add this to my saved trials
2603
mi
from 98109
Melbourne, FL
Click here to add this to my saved trials
1674
mi
from 98109
Menomonee Falls, WI
Click here to add this to my saved trials
1687
mi
from 98109
Milwaukee, WI
Click here to add this to my saved trials
2151
mi
from 98109
Mobile, AL
Click here to add this to my saved trials
2099
mi
from 98109
New Orleans, LA
Click here to add this to my saved trials
2106
mi
from 98109
New Tazewell, TN
Click here to add this to my saved trials
2354
mi
from 98109
Newark, DE
Click here to add this to my saved trials
1420
mi
from 98109
Newton, KS
Click here to add this to my saved trials
2431
mi
from 98109
Norfolk, VA
Click here to add this to my saved trials
2426
mi
from 98109
Northport, NY
Click here to add this to my saved trials
1523
mi
from 98109
Oklahoma City, OK
Click here to add this to my saved trials
1998
mi
from 98109
Olmstead Township, OH
Click here to add this to my saved trials
1366
mi
from 98109
Omaha, NE
Click here to add this to my saved trials
2327
mi
from 98109
Oxon Hill, MD
Click here to add this to my saved trials
2281
mi
from 98109
Panama City, FL
Click here to add this to my saved trials
2716
mi
from 98109
Pembroke Pines, FL
Click here to add this to my saved trials
2378
mi
from 98109
Penndel, PA
Click here to add this to my saved trials
1678
mi
from 98109
Peoria, IL
Click here to add this to my saved trials
Philadelphia, Pennsylvania
2373
mi
from 98109
Philadelphia, PA
Click here to add this to my saved trials
147
mi
from 98109
Portland, OR
Click here to add this to my saved trials
2361
mi
from 98109
Raleigh, NC
Click here to add this to my saved trials
974
mi
from 98109
Redondo Beach, CA
Click here to add this to my saved trials
977
mi
from 98109
Riverside, CA
Click here to add this to my saved trials
2161
mi
from 98109
Rochester, NY
Click here to add this to my saved trials
627
mi
from 98109
Sacramento, CA
Click here to add this to my saved trials
1720
mi
from 98109
Saint Louis, MO
Click here to add this to my saved trials
2281
mi
from 98109
Salisbury, NC
Click here to add this to my saved trials
701
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
1065
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
680
mi
from 98109
San Francisco, CA
Click here to add this to my saved trials
?
mi
from 98109
Sandy, UT
Click here to add this to my saved trials
987
mi
from 98109
Santa Ana, CA
Click here to add this to my saved trials
1929
mi
from 98109
Selmer, TN
Click here to add this to my saved trials
2429
mi
from 98109
Ship Bottom, NJ
Click here to add this to my saved trials
1803
mi
from 98109
South Bend, IN
Click here to add this to my saved trials
1066
mi
from 98109
Spring Valley, CA
Click here to add this to my saved trials
2238
mi
from 98109
Springfield, PA
Click here to add this to my saved trials
26
mi
from 98109
Tacoma, WA
Click here to add this to my saved trials
1921
mi
from 98109
Troy, MI
Click here to add this to my saved trials
1558
mi
from 98109
Tulsa, CA
Click here to add this to my saved trials
1558
mi
from 98109
Tulsa, OK
Click here to add this to my saved trials
2384
mi
from 98109
Turnersville, NJ
Click here to add this to my saved trials
1435
mi
from 98109
Wichita, KS
Click here to add this to my saved trials
2114
mi
from 98109
Williamsville, NY
Click here to add this to my saved trials
2275
mi
from 98109
Winston-Salem, NC
Click here to add this to my saved trials