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
334
mi
from
Carrollton, TX
Click here to add this to my saved trials
637
mi
from
Athens, AL
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
1265
mi
from
Berlin, NJ
Click here to add this to my saved trials
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
430
mi
from
Boulder, CO
Click here to add this to my saved trials
780
mi
from
Bountiful, UT
Click here to add this to my saved trials
1287
mi
from
Brooklyn, NY
Click here to add this to my saved trials
556
mi
from
Brooklyn Center, MN
Click here to add this to my saved trials
1159
mi
from
Buena Park, CA
Click here to add this to my saved trials
1020
mi
from
Burlington, NC
Click here to add this to my saved trials
395
mi
from
Carlisle, AR
Click here to add this to my saved trials
Charlotte, North Carolina
958
mi
from
Charlotte, NC
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
726
mi
from
Cincinnati, OH
Click here to add this to my saved trials
810
mi
from
Columbus, OH
Click here to add this to my saved trials
823
mi
from
Conyers, GA
Click here to add this to my saved trials
1319
mi
from
Coral Gables, FL
Click here to add this to my saved trials
482
mi
from
Cordova, TN
Click here to add this to my saved trials
348
mi
from
Dallas, TX
Click here to add this to my saved trials
805
mi
from
Decatur, GA
Click here to add this to my saved trials
1124
mi
from
Deland, FL
Click here to add this to my saved trials
1425
mi
from
East Providence, RI
Click here to add this to my saved trials
546
mi
from
Edina, MN
Click here to add this to my saved trials
1141
mi
from
Encinitas, CA
Click here to add this to my saved trials
984
mi
from
Erie, PA
Click here to add this to my saved trials
559
mi
from
Evansville, IN
Click here to add this to my saved trials
1119
mi
from
Falls Church, VA
Click here to add this to my saved trials
1352
mi
from
Farmington, CT
Click here to add this to my saved trials
1307
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
856
mi
from
Glendale, AZ
Click here to add this to my saved trials
1343
mi
from
Greenbrae, CA
Click here to add this to my saved trials
1286
mi
from
Hamburg, NY
Click here to add this to my saved trials
1213
mi
from
Harleysville, PA
Click here to add this to my saved trials
405
mi
from
Highlands Ranch, CO
Click here to add this to my saved trials
1311
mi
from
Hollywood, FL
Click here to add this to my saved trials
659
mi
from
Huntsville, AL
Click here to add this to my saved trials
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
520
mi
from
Jackson, TN
Click here to add this to my saved trials
198
mi
from
Kansas City, MO
Click here to add this to my saved trials
747
mi
from
Kettering, OH
Click here to add this to my saved trials
458
mi
from
Killeen, TX
Click here to add this to my saved trials
222 Broadway
Kissimmee, Florida 34741
1150
mi
from
Kissimmee, FL
Click here to add this to my saved trials
1103
mi
from
Largo, FL
Click here to add this to my saved trials
960
mi
from
Las Vegas, NV
Click here to add this to my saved trials
1172
mi
from
Long Beach, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
656
mi
from
Louisville, KY
Click here to add this to my saved trials
1198
mi
from
Melbourne, FL
Click here to add this to my saved trials
632
mi
from
Menomonee Falls, WI
Click here to add this to my saved trials
636
mi
from
Milwaukee, WI
Click here to add this to my saved trials
740
mi
from
Mobile, AL
Click here to add this to my saved trials
697
mi
from
New Orleans, LA
Click here to add this to my saved trials
788
mi
from
New Tazewell, TN
Click here to add this to my saved trials
1193
mi
from
Newark, DE
Click here to add this to my saved trials
33
mi
from
Newton, KS
Click here to add this to my saved trials
1182
mi
from
Norfolk, VA
Click here to add this to my saved trials
1321
mi
from
Northport, NY
Click here to add this to my saved trials
158
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
819
mi
from
Olmstead Township, OH
Click here to add this to my saved trials
262
mi
from
Omaha, NE
Click here to add this to my saved trials
1129
mi
from
Oxon Hill, MD
Click here to add this to my saved trials
870
mi
from
Panama City, FL
Click here to add this to my saved trials
1306
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
1238
mi
from
Penndel, PA
Click here to add this to my saved trials
485
mi
from
Peoria, IL
Click here to add this to my saved trials
Philadelphia, Pennsylvania
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1383
mi
from
Portland, OR
Click here to add this to my saved trials
1068
mi
from
Raleigh, NC
Click here to add this to my saved trials
1181
mi
from
Redondo Beach, CA
Click here to add this to my saved trials
1122
mi
from
Riverside, CA
Click here to add this to my saved trials
1122
mi
from
Rochester, NY
Click here to add this to my saved trials
1283
mi
from
Sacramento, CA
Click here to add this to my saved trials
418
mi
from
Saint Louis, MO
Click here to add this to my saved trials
970
mi
from
Salisbury, NC
Click here to add this to my saved trials
779
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
1339
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Sandy, UT
Click here to add this to my saved trials
1155
mi
from
Santa Ana, CA
Click here to add this to my saved trials
542
mi
from
Selmer, TN
Click here to add this to my saved trials
1277
mi
from
Ship Bottom, NJ
Click here to add this to my saved trials
671
mi
from
South Bend, IN
Click here to add this to my saved trials
1133
mi
from
Spring Valley, CA
Click here to add this to my saved trials
1122
mi
from
Springfield, PA
Click here to add this to my saved trials
1407
mi
from
Tacoma, WA
Click here to add this to my saved trials
841
mi
from
Troy, MI
Click here to add this to my saved trials
149
mi
from
Tulsa, CA
Click here to add this to my saved trials
149
mi
from
Tulsa, OK
Click here to add this to my saved trials
1231
mi
from
Turnersville, NJ
Click here to add this to my saved trials
26
mi
from
Wichita, KS
Click here to add this to my saved trials
1064
mi
from
Williamsville, NY
Click here to add this to my saved trials
976
mi
from
Winston-Salem, NC
Click here to add this to my saved trials