HypertensionPhase 4NCT00240448

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

A Phase 4 study testing telmisartan 80 mg/hydrochlorothiazide 25 mg and valsartan 160 mg/hydrochlorothiazide 25 mg in people with Hypertension, run by Boehringer Ingelheim at 100 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: telmisartan 80 mg/hydrochlorothiazide 25 mg and valsartan 160 mg/hydrochlorothiazide 25 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,109 participants
Where: 100 sitesUnited States
Study dates: Sep 2003to Jun 2004
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

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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, cholestasis or moderate to severe hepatic insufficiency.
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, etc.
Any investigational drug therapy within one month of start of run-in period.
known hypersensitivity to any component of the formulation study drugs (telmisartan, valsartan, HCT).
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.
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.
Night shift workers.
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
NYHA functional class CHF III-IV.
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
Patients whose diabetes has been unstable and uncontrolled for at least the past 3 months as defined by a HbA1c >/= 10%.
Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCT).
History of non-compliance with prescribed medication or protocol procedures.

Trial locations and contacts

100 sites in 1 country.

City, postcode or hospital

100 sites in 1 country

United States100 sites

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

Other trials in United States

About this study

Official title: 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

Conditions: Hypertension
Being tested: telmisartan 80 mg/hydrochlorothiazide 25 mg, valsartan 160 mg/hydrochlorothiazide 25 mg, placebo
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

telmisartan 80 mg/hydrochlorothiazide 25 mgDrug
valsartan 160 mg/hydrochlorothiazide 25 mgDrug
placeboDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2003Jun 2004

First posted18 Oct 2005 (estimated)
Study startSep 2003
Primary completionJun 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00240448
Sponsor's protocol ID: 502.421
Status last verified: Nov 2013
First submitted: 14 Oct 2005
Last updated: 5 Nov 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00240448
Acronym / sponsor ID: 502.421
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,109 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2003
Primary completion: Jun 2004 (actual)
First posted: 18 Oct 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (30 listed)

Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:
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:
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
telmisartan 80 mg/hydrochlorothiazide 25 mg	Drug	–
valsartan 160 mg/hydrochlorothiazide 25 mg	Drug	–
placebo	Drug	–

Primary outcome

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

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim Study Coordinator study chair

Boehringer Ingelheim

100 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00240448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.