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

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00168779
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean seated trough cuff DBP and SBP	after 8 week

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (113)

502.476.064 Boehringer Ingelheim Investigational Site; 🇺🇸 Kettering, Ohio, United States

502.476.003 Boehringer Ingelheim Investigational Site; 🇺🇸 Wichita, Kansas, United States

502.476.086 Boehringer Ingelheim Investigational Site; 🇺🇸 Encinitas, California, United States

502.476.080 Boehringer Ingelheim Investigational Site; 🇺🇸 Melbourne, Florida, United States

502.476.065 Boehringer Ingelheim Investigational Site; 🇺🇸 Pembroke Pines, Florida, United States

502.476.075 Boehringer Ingelheim Investigational Site; 🇺🇸 Decatur, Georgia, United States

502.476.074 Boehringer Ingelheim Investigational Site; 🇺🇸 Athens, Alabama, United States

502.476.108 Boehringer Ingelheim Investigational Site; 🇺🇸 DeLand, Florida, United States

502.476.012 Boehringer Ingelheim Investigational Site; 🇺🇸 Pembroke Pines, Florida, United States

502.476.062 Boehringer Ingelheim Investigational Site; 🇺🇸 Evansville, Indiana, United States

502.476.038 Boehringer Ingelheim Investigational Site; 🇺🇸 Wichita, Kansas, United States

502.476.030 Boehringer Ingelheim Investigational Site; 🇺🇸 Tulsa, Oklahoma, United States

502.476.010 Boehringer Ingelheim Investigational Site; 🇺🇸 Troy, Michigan, United States

502.476.001 Boehringer Ingelheim Investigational Site; 🇺🇸 Bountiful, Utah, United States

502.476.091 Boehringer Ingelheim Investigational Site; 🇺🇸 Williamsville, New York, United States

502.476.120 Boehringer Ingelheim Investigational Site; 🇺🇸 Berlin, New Jersey, United States

502.476.116 Boehringer Ingelheim Investigational Site; 🇺🇸 New Orleans, Louisiana, United States

502.476.039 Boehringer Ingelheim Investigational Site; 🇺🇸 Carrollton, Texas, United States

502.476.103 Boehringer Ingelheim Investigational Site; 🇺🇸 Olmstead Township, Ohio, United States

502.476.056 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

502.476.089 Boehringer Ingelheim Investigational Site; 🇺🇸 Turnersville, New Jersey, United States

502.476.063 Boehringer Ingelheim Investigational Site; 🇺🇸 Evansville, Indiana, United States

502.476.097 Boehringer Ingelheim Investigational Site; 🇺🇸 Sandy, Utah, United States

502.476.114 Boehringer Ingelheim Investigational Site; 🇺🇸 Saint Louis, Missouri, United States

502.476.122 Boehringer Ingelheim Investigational Site; 🇺🇸 Hamburg, New York, United States

502.476.082 Boehringer Ingelheim Investigational Site; 🇺🇸 Selmer, Tennessee, United States

502.476.069 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

502.476.025 Boehringer Ingelheim Investigational Site; 🇺🇸 Rochester, New York, United States

502.476.070 Boehringer Ingelheim Investigational Site; 🇺🇸 Killeen, Texas, United States

502.476.093 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

502.476.068 Boehringer Ingelheim Investigational Site; 🇺🇸 Brooklyn, New York, United States

502.476.078 Boehringer Ingelheim Investigational Site; 🇺🇸 Tacoma, Washington, United States

502.476.046 Boehringer Ingelheim Investigational Site; 🇺🇸 Burlington, North Carolina, United States

502.476.024 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

502.476.022 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

502.476.018 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

502.476.047 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

502.476.016 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

502.476.023 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

502.476.128 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

502.476.051 Boehringer Ingelheim Investigational Site; 🇺🇸 Indianapolis, Indiana, United States

502.476.035 Boehringer Ingelheim Investigational Site; 🇺🇸 Oxon Hill, Maryland, United States

502.476.087 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

502.476.125 Boehringer Ingelheim Investigational Site; 🇺🇸 Las Vegas, Nevada, United States

502.476.034 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

502.476.060 Boehringer Ingelheim Investigational Site; 🇺🇸 Cincinnati, Ohio, United States

502.476.111 Boehringer Ingelheim Investigational Site; 🇺🇸 San Francisco, California, United States

502.476.006 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

502.476.017 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

502.476.059 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

502.476.079 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

502.476.112 Boehringer Ingelheim Investigational Site; 🇺🇸 Omaha, Nebraska, United States

502.476.071 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

502.476.126 Boehringer Ingelheim Investigational Site; 🇺🇸 Omaha, Nebraska, United States

502.476.007 Boehringer Ingelheim Investigational Site; 🇺🇸 Oklahoma City, Oklahoma, United States

502.476.113 Boehringer Ingelheim Investigational Site; 🇺🇸 Oklahoma City, Oklahoma, United States

502.476.104 Boehringer Ingelheim Investigational Site; 🇺🇸 Portland, Oregon, United States

502.476.105 Boehringer Ingelheim Investigational Site; 🇺🇸 Milwaukee, Wisconsin, United States

502.476.098 Boehringer Ingelheim Investigational Site; 🇺🇸 Sandy, Utah, United States

502.476.095 Boehringer Ingelheim Investigational Site; 🇺🇸 Salisbury, North Carolina, United States

502.476.107 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

502.476.014 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

502.476.031 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

502.476.066 Boehringer Ingelheim Investigational Site; 🇺🇸 Carlisle, Arkansas, United States

502.476.110 Boehringer Ingelheim Investigational Site; 🇺🇸 Huntsville, Alabama, United States

502.476.061 Boehringer Ingelheim Investigational Site; 🇺🇸 Glendale, Arizona, United States

502.476.037 Boehringer Ingelheim Investigational Site; 🇺🇸 Mobile, Alabama, United States

502.476.124 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenbrae, California, United States

502.476.067 Boehringer Ingelheim Investigational Site; 🇺🇸 Buena Park, California, United States

502.476.029 Boehringer Ingelheim Investigational Site; 🇺🇸 Redondo Beach, California, United States

502.476.026 Boehringer Ingelheim Investigational Site; 🇺🇸 Spring Valley, California, United States

502.476.033 Boehringer Ingelheim Investigational Site; 🇺🇸 Tulsa, California, United States

502.476.048 Boehringer Ingelheim Investigational Site; 🇺🇸 Riverside, California, United States

502.476.050 Boehringer Ingelheim Investigational Site; 🇺🇸 Santa Ana, California, United States

502.476.019 Boehringer Ingelheim Investigational Site; 🇺🇸 Boulder, Colorado, United States

502.476.032 Boehringer Ingelheim Investigational Site; 🇺🇸 Newark, Delaware, United States

502.476.053 Boehringer Ingelheim Investigational Site; 🇺🇸 Farmington, Connecticut, United States

502.476.101 Boehringer Ingelheim Investigational Site; 🇺🇸 Highlands Ranch, Colorado, United States

502.476.041 Boehringer Ingelheim Investigational Site; 🇺🇸 Coral Gables, Florida, United States

502.476.015 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Lauderdale, Florida, United States

502.476.058 FPA Clinical Research; 🇺🇸 Kissimmee, Florida, United States

502.476.052 Boehringer Ingelheim Investigational Site; 🇺🇸 Largo, Florida, United States

502.476.044 Boehringer Ingelheim Investigational Site; 🇺🇸 Hollywood, Florida, United States

502.476.021 Boehringer Ingelheim Investigational Site; 🇺🇸 Panama City, Florida, United States

502.476.036 Boehringer Ingelheim Investigational Site; 🇺🇸 Pembroke Pines, Florida, United States

502.476.008 Boehringer Ingelheim Investigational Site; 🇺🇸 Conyers, Georgia, United States

502.476.049 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

502.476.004 Boehringer Ingelheim Investigational Site; 🇺🇸 Peoria, Illinois, United States

502.476.084 Boehringer Ingelheim Investigational Site; 🇺🇸 South Bend, Indiana, United States

502.476.100 Boehringer Ingelheim Investigational Site; 🇺🇸 Newton, Kansas, United States

502.476.090 Boehringer Ingelheim Investigational Site; 🇺🇸 South Bend, Indiana, United States

502.476.057 Boehringer Ingelheim Investigational Site; 🇺🇸 Edina, Minnesota, United States

502.476.028 Boehringer Ingelheim Investigational Site; 🇺🇸 Brooklyn Center, Minnesota, United States

502.476.088 Boehringer Ingelheim Investigational Site; 🇺🇸 Ship Bottom, New Jersey, United States

502.476.020 Boehringer Ingelheim Investigational Site; 🇺🇸 Northport, New York, United States

502.476.042 Boehringer Ingelheim Investigational Site; 🇺🇸 Raleigh, North Carolina, United States

502.476.083 Boehringer Ingelheim Investigational Site; 🇺🇸 Charlotte, North Carolina, United States

502.476.094 Boehringer Ingelheim Investigational Site; 🇺🇸 Harleysville, Pennsylvania, United States

502.476.109 Boehringer Ingelheim Investigational Site; 🇺🇸 Erie, Pennsylvania, United States

502.476.121 Boehringer Ingelheim Investigational Site; 🇺🇸 Penndel, Pennsylvania, United States

502.476.072 Boehringer Ingelheim Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States

502.476.076 Boehringer Ingelheim Investigational Site; 🇺🇸 Springfield, Pennsylvania, United States

502.476.013 Boehringer Ingelheim Investigational Site; 🇺🇸 East Providence, Rhode Island, United States

502.476.085 Boehringer Ingelheim Investigational Site; 🇺🇸 Cordova, Tennessee, United States

502.476.096 Boehringer Ingelheim Investigational Site; 🇺🇸 Jackson, Tennessee, United States

502.476.081 Boehringer Ingelheim Investigational Site; 🇺🇸 New Tazewell, Tennessee, United States

502.476.011 Boehringer Ingelheim Investigational Site; 🇺🇸 Falls Church, Virginia, United States

502.476.106 Boehringer Ingelheim Investigational Site; 🇺🇸 Menomonee Falls, Wisconsin, United States

502.476.005 Boehringer Ingelheim Investigational Site; 🇺🇸 Long Beach, California, United States

502.476.073 Boehringer Ingelheim Investigational Site; 🇺🇸 Sacramento, California, United States

502.476.002 Boehringer Ingelheim Investigational Site; 🇺🇸 Louisville, Kentucky, United States

502.476.055 Boehringer Ingelheim Investigational Site; 🇺🇸 Kansas City, Missouri, United States

502.476.027 Boehringer Ingelheim Investigational Site; 🇺🇸 Winston-Salem, North Carolina, United States