A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Forced-titration, Comparison of MICARDIS® HCT (Telmisartan 80 mg / Hydrochlorothiazide 25 mg) Versus DIOVAN® HCT (Valsartan 160 mg / Hydrochlorothiazide 25 mg) Using Seated Trough Cuff Blood Pressure in Patients With Stage 1 and 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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: placebo; Drug: telmisartan 80 mg/hydrochlorothiazide 25 mg; Drug: valsartan 160 mg/hydrochlorothiazide 25 mg

• Study Type: Interventional
• Enrollment (Actual): 1109
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Boehringer Ingelheim Investigational Site
    • Huntsville, Alabama, United States
      • Boehringer Ingelheim Investigational Site
    • Mobile, Alabama, United States
      • Boehringer Ingelheim Investigational Site
  • Arizona
    • Sctoosdale, Arizona, United States
      • Boehringer Ingelheim Investigational Site
    • Tucson, Arizona, United States
      • Boehringer Ingelheim Investigational Site
  • Arkansas
    • Bentonville, Arkansas, United States
      • Boehringer Ingelheim Investigational Site
    • Carlisle, Arkansas, United States
      • Boehringer Ingelheim Investigational Site
    • Hot Springs, Arkansas, United States
      • Boehringer Ingelheim Investigational Site
  • California
    • Concord, California, United States
      • Boehringer Ingelheim Investigational Site
    • Long Beach, California, United States
      • Memorial Research Medical Clinic
    • Orange, California, United States
      • Boehringer Ingelheim Investigational Site
    • Riverside, California, United States
      • Boehringer Ingelheim Investigational Site
    • Roseville, California, United States
      • Clinical Trials Research
    • Sacramento, California, United States
      • Boehringer Ingelheim Investigational Site
    • San Leandro, California, United States
      • Boehringer Ingelheim Investigational Site
    • Santa Ana, California, United States
      • Boehringer Ingelheim Investigational Site
    • Sepulveda, California, United States
      • Boehringer Ingelheim Investigational Site
    • Spring Valley, California, United States
      • Boehringer Ingelheim Investigational Site
    • Torrance, California, United States
      • Boehringer Ingelheim Investigational Site
  • Colorado
    • Boulder, Colorado, United States
      • Boehringer Ingelheim Investigational Site
  • Connecticut
    • Bridgeport, Connecticut, United States
      • Boehringer Ingelheim Investigational Site
    • Farmington, Connecticut, United States
      • Boehringer Ingelheim Investigational Site
    • Trumbull, Connecticut, United States
      • Clinical Research Consultants, Inc.
    • Waterbury, Connecticut, United States
      • Boehringer Ingelheim Investigational Site
  • Delaware
    • Newark, Delaware, United States
      • Boehringer Ingelheim Investigational Site
  • Florida
    • Coral Gables, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Ft. Lauderdale, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Ft. Myers, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Holiday, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Hollywood, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Kissimmee, Florida, United States
      • Christopher Chappel, MD
    • Largo, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Orlando, Florida, United States
      • Orlando Clinical Research Center
    • Palm Harbor, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Panama City, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Pembroke Pines, Florida, United States
      • Boehringer Ingelheim Investigational Site
    • Pembroke Pines, Florida, United States
      • Attention: Larry I. Gilderman, D.O.
  • Georgia
    • Atlanta, Georgia, United States
      • Grady Memorial Hospital
    • Atlanta, Georgia, United States
      • Boehringer Ingelheim Investigational Site
    • Conyers, Georgia, United States
      • Boehringer Ingelheim Investigational Site
  • Idaho
    • Boise, Idaho, United States
      • Treasure Valley Cardiology
  • Illinois
    • Chicago, Illinois, United States
      • Boehringer Ingelheim Investigational Site
    • Chicago, Illinois, United States
      • Cedar-Crosse Research Center
    • Chicago, Illinois, United States
      • Herron Medical Center, Ltd.
    • Orland Park, Illinois, United States
      • Boehringer Ingelheim Investigational Site
    • Peoria, Illinois, United States
      • N Touch Research
  • Indiana
    • Indianapolis, Indiana, United States
      • Midwest Institute for Clinical Research Inc.
  • Iowa
    • Waterloo, Iowa, United States
      • Boehringer Ingelheim Investigational Site
  • Kansas
    • Shawnee, Kansas, United States
      • Boehringer Ingelheim Investigational Site
    • Wichita, Kansas, United States
      • Boehringer Ingelheim Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States
      • Boehringer Ingelheim Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States
      • Attn:William Smith
  • Maryland
    • Baltimore, Maryland, United States
      • Boehringer Ingelheim Investigational Site
  • Massachusetts
    • Brookline, Massachusetts, United States
      • Boehringer Ingelheim Investigational Site
    • Waltham, Massachusetts, United States
      • Waltham Hospital
  • Michigan
    • Troy, Michigan, United States
      • Boehringer Ingelheim Investigational Site
  • Minnesota
    • Brooklyn Center, Minnesota, United States
      • Boehringer Ingelheim Investigational Site
    • Edina, Minnesota, United States
      • Radiant Research
  • Mississippi
    • Jackson, Mississippi, United States
      • Boehringer Ingelheim Investigational Site
  • Missouri
    • Kansas City, Missouri, United States
      • Boehringer Ingelheim Investigational Site
  • New Jersey
    • Camden, New Jersey, United States
      • Department of Medicine
    • Cherry Hill, New Jersey, United States
      • Boehringer Ingelheim Investigational Site
  • New York
    • Bronx, New York, United States
      • Boehringer Ingelheim Investigational Site
    • Kingston, New York, United States
      • Boehringer Ingelheim Investigational Site
    • Northport, New York, United States
      • Northport VAMC - Medical Service (111)
    • Rochester, New York, United States
      • Boehringer Ingelheim Investigational Site
    • Scarsdale, New York, United States
      • Boehringer Ingelheim Investigational Site
  • North Carolina
    • Burlington, North Carolina, United States
      • Boehringer Ingelheim Investigational Site
    • Cary, North Carolina, United States
      • Boehringer Ingelheim Investigational Site
    • Durham, North Carolina, United States
      • Boehringer Ingelheim Investigational Site
    • Raleigh, North Carolina, United States
      • Boehringer Ingelheim Investigational Site
    • Stateville, North Carolina, United States
      • Boehringer Ingelheim Investigational Site
    • Winston-Salem, North Carolina, United States
      • Boehringer Ingelheim Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States
      • Boehringer Ingelheim Investigational Site
    • Cincinnati, Ohio, United States
      • Radiant Reseach
    • Columbus, Ohio, United States
      • Ohio State University
    • Columbus, Ohio, United States
      • Radiant Research
    • Columbus, Ohio, United States
      • Boehringer Ingelheim Investigational Site
    • Mansfield, Ohio, United States
      • Boehringer Ingelheim Investigational Site
    • Mogadore, Ohio, United States
      • Boehringer Ingelheim Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Boehringer Ingelheim Investigational Site
    • Tulsa, Oklahoma, United States
      • Boehringer Ingelheim Investigational Site
  • Pennsylvania
    • Collegeville, Pennsylvania, United States
      • Bock Clinical Research
    • Philadelphia, Pennsylvania, United States
      • Boehringer Ingelheim Investigational Site
    • Pottstown, Pennsylvania, United States
      • Boehringer Ingelheim Investigational Site
  • Rhode Island
    • East Providence, Rhode Island, United States
      • Boehringer Ingelheim Investigational Site
  • South Carolina
    • Greer, South Carolina, United States
      • Boehringer Ingelheim Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States
      • Boehringer Ingelheim Investigational Site
  • Texas
    • Austin, Texas, United States
      • Boehringer Ingelheim Investigational Site
    • Carrollton, Texas, United States
      • Boehringer Ingelheim Investigational Site
    • Dallas, Texas, United States
      • Boehringer Ingelheim Investigational Site
    • Houston, Texas, United States
      • Boehringer Ingelheim Investigational Site
    • McKinney, Texas, United States
      • Boehringer Ingelheim Investigational Site
    • San Antonio, Texas, United States
      • Boehringer Ingelheim Investigational Site
  • Utah
    • Salt Lake City, Utah, United States
      • Boehringer Ingelheim Investigational Site
  • Virginia
    • Falls Church, Virginia, United States
      • Clinical Research Center of N. VA
  • Washington
    • Lacey, Washington, United States
      • Boehringer Ingelheim Investigational Site
    • Lakewood, Washington, United States
      • Boehringer Ingelheim Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States
      • Boehringer Ingelheim Investigational Site
    • Milwaukee, Wisconsin, United States
      • Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

   • 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).
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:

   • 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.
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, cholestasis or moderate to severe hepatic insufficiency.
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, etc.
15. Any investigational drug therapy within one month of start of run-in period.
16. known hypersensitivity to any component of the formulation study drugs (telmisartan, valsartan, HCT).
17. Contra-indication to a placebo run-in period (e.g. stroke within the past six months, MI, cardia surgery, PTCA or angina within the past three months prior to the start of run-in period.
18. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan, valsartan, or HCT.
19. Night shift workers.
20. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
21. NYHA functional class CHF III-IV.
22. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
23. Patients whose diabetes has been unstable and uncontrolled for at least the past 3 months as defined by a HbA1c >/= 10%.
24. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCT).
25. History of non-compliance with prescribed medication or protocol procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period

Secondary Outcome Measures

Outcome Measure
Percentage of responders based on change from baseline in cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: October 14, 2005
• First Submitted That Met QC Criteria: October 14, 2005
• First Posted (Estimate): October 18, 2005

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Valsartan; Hydrochlorothiazide; Telmisartan
• Other Study ID Numbers: 502.421