HypertensionPhase 4NCT00168779

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

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 113 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: 1,185 participants
Where: 113 sitesUnited States
Study dates: Sep 2005to Jul 2006
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.

Show all 19Show fewer

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, cholestatis or moderate to severe hepatic in sufficiency.
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, exc

Trial locations and contacts

113 sites in 1 country.

City, postcode or hospital

113 sites in 1 country

United States113 sites

502.476.074 Boehringer Ingelheim Investigational Site
Athens, Alabama
502.476.022 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
502.476.049 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
502.476.120 Boehringer Ingelheim Investigational Site
Berlin, New Jersey
502.476.059 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
502.476.071 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
502.476.079 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
502.476.019 Boehringer Ingelheim Investigational Site
Boulder, Colorado
502.476.001 Boehringer Ingelheim Investigational Site
Bountiful, Utah
502.476.068 Boehringer Ingelheim Investigational Site
Brooklyn, New York
502.476.028 Boehringer Ingelheim Investigational Site
Brooklyn Center, Minnesota
502.476.067 Boehringer Ingelheim Investigational Site
Buena Park, California
502.476.046 Boehringer Ingelheim Investigational Site
Burlington, North Carolina
502.476.066 Boehringer Ingelheim Investigational Site
Carlisle, Arkansas
502.476.039 Boehringer Ingelheim Investigational Site
Carrollton, Texas
502.476.083 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
502.476.018 Boehringer Ingelheim Investigational Site
Chicago, Illinois
502.476.047 Boehringer Ingelheim Investigational Site
Chicago, Illinois
502.476.034 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
502.476.060 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
502.476.016 Boehringer Ingelheim Investigational Site
Columbus, Ohio
502.476.023 Boehringer Ingelheim Investigational Site
Columbus, Ohio
502.476.128 Boehringer Ingelheim Investigational Site
Columbus, Ohio
502.476.008 Boehringer Ingelheim Investigational Site
Conyers, Georgia
502.476.041 Boehringer Ingelheim Investigational Site
Coral Gables, Florida
502.476.085 Boehringer Ingelheim Investigational Site
Cordova, Tennessee
502.476.056 Boehringer Ingelheim Investigational Site
Dallas, Texas
502.476.069 Boehringer Ingelheim Investigational Site
Dallas, Texas
502.476.107 Boehringer Ingelheim Investigational Site
Dallas, Texas
502.476.075 Boehringer Ingelheim Investigational Site
Decatur, Georgia
502.476.108 Boehringer Ingelheim Investigational Site
DeLand, Florida
502.476.013 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island
502.476.057 Boehringer Ingelheim Investigational Site
Edina, Minnesota
502.476.086 Boehringer Ingelheim Investigational Site
Encinitas, California
502.476.109 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania
502.476.062 Boehringer Ingelheim Investigational Site
Evansville, Indiana
502.476.063 Boehringer Ingelheim Investigational Site
Evansville, Indiana
502.476.011 Boehringer Ingelheim Investigational Site
Falls Church, Virginia
502.476.053 Boehringer Ingelheim Investigational Site
Farmington, Connecticut
502.476.015 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
502.476.061 Boehringer Ingelheim Investigational Site
Glendale, Arizona
502.476.124 Boehringer Ingelheim Investigational Site
Greenbrae, California
502.476.122 Boehringer Ingelheim Investigational Site
Hamburg, New York
502.476.094 Boehringer Ingelheim Investigational Site
Harleysville, Pennsylvania
502.476.101 Boehringer Ingelheim Investigational Site
Highlands Ranch, Colorado
502.476.044 Boehringer Ingelheim Investigational Site
Hollywood, Florida
502.476.014 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
502.476.031 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
502.476.110 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
502.476.051 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
502.476.096 Boehringer Ingelheim Investigational Site
Jackson, Tennessee
502.476.055 Boehringer Ingelheim Investigational Site
Kansas City, Missouri
502.476.064 Boehringer Ingelheim Investigational Site
Kettering, Ohio
502.476.070 Boehringer Ingelheim Investigational Site
Killeen, Texas
502.476.058 FPA Clinical Research
Kissimmee, Florida
502.476.052 Boehringer Ingelheim Investigational Site
Largo, Florida
502.476.125 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada
502.476.005 Boehringer Ingelheim Investigational Site
Long Beach, California
502.476.024 Boehringer Ingelheim Investigational Site
Los Angeles, California
502.476.002 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
502.476.080 Boehringer Ingelheim Investigational Site
Melbourne, Florida
502.476.106 Boehringer Ingelheim Investigational Site
Menomonee Falls, Wisconsin
502.476.105 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
502.476.037 Boehringer Ingelheim Investigational Site
Mobile, Alabama
502.476.116 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
502.476.081 Boehringer Ingelheim Investigational Site
New Tazewell, Tennessee
502.476.032 Boehringer Ingelheim Investigational Site
Newark, Delaware
502.476.100 Boehringer Ingelheim Investigational Site
Newton, Kansas
502.476.093 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
502.476.020 Boehringer Ingelheim Investigational Site
Northport, New York
502.476.007 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
502.476.113 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
502.476.103 Boehringer Ingelheim Investigational Site
Olmsted Falls, Ohio
502.476.112 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
502.476.126 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
502.476.035 Boehringer Ingelheim Investigational Site
Oxon Hill, Maryland
502.476.021 Boehringer Ingelheim Investigational Site
Panama City, Florida
502.476.012 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
502.476.036 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
502.476.065 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
502.476.121 Boehringer Ingelheim Investigational Site
Penndel, Pennsylvania
502.476.004 Boehringer Ingelheim Investigational Site
Peoria, Illinois
502.476.072 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
502.476.104 Boehringer Ingelheim Investigational Site
Portland, Oregon
502.476.042 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
502.476.029 Boehringer Ingelheim Investigational Site
Redondo Beach, California
502.476.048 Boehringer Ingelheim Investigational Site
Riverside, California
502.476.025 Boehringer Ingelheim Investigational Site
Rochester, New York
502.476.073 Boehringer Ingelheim Investigational Site
Sacramento, California
502.476.095 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina
502.476.006 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
502.476.017 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
502.476.087 Boehringer Ingelheim Investigational Site
San Diego, California
502.476.111 Boehringer Ingelheim Investigational Site
San Francisco, California
502.476.097 Boehringer Ingelheim Investigational Site
Sandy City, Utah
502.476.098 Boehringer Ingelheim Investigational Site
Sandy City, Utah
502.476.050 Boehringer Ingelheim Investigational Site
Santa Ana, California
502.476.082 Boehringer Ingelheim Investigational Site
Selmer, Tennessee
502.476.088 Boehringer Ingelheim Investigational Site
Ship Bottom, New Jersey
502.476.084 Boehringer Ingelheim Investigational Site
South Bend, Indiana
502.476.090 Boehringer Ingelheim Investigational Site
South Bend, Indiana
502.476.026 Boehringer Ingelheim Investigational Site
Spring Valley, California
502.476.076 Boehringer Ingelheim Investigational Site
Springfield, Pennsylvania
502.476.114 Boehringer Ingelheim Investigational Site
St Louis, Missouri
502.476.078 Boehringer Ingelheim Investigational Site
Tacoma, Washington
502.476.010 Boehringer Ingelheim Investigational Site
Troy, Michigan
502.476.033 Boehringer Ingelheim Investigational Site
Tulsa, California
502.476.030 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma
502.476.089 Boehringer Ingelheim Investigational Site
Turnersville, New Jersey
502.476.003 Boehringer Ingelheim Investigational Site
Wichita, Kansas
502.476.038 Boehringer Ingelheim Investigational Site
Wichita, Kansas
502.476.091 Boehringer Ingelheim Investigational Site
Williamsville, New York
502.476.027 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

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About this study

Official title: 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.

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.

Mean seated trough cuff DBP and SBP
Measured: after 8 week

Secondary outcomes (3)

The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements
Measured: after 8 week
The percentage of patients with uncontrolled hypertension
Measured: after 8 weeks
Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points
Measured: after 8 weeks

Timeline

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

Sep 2005Jul 2006

First posted15 Sep 2005 (estimated)
Study startSep 2005
Primary completionJul 2006
Study completionJul 2006

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
Intervention model: Parallel groups
Enrolment: 1,185 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00168779
Sponsor's protocol ID: 502.476
Status last verified: Dec 2017
First submitted: 12 Sep 2005
Last updated: 28 Dec 2017
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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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT00168779
Acronym / sponsor ID: 502.476
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,185 participants
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Jul 2006 (actual)
Study completion: Jul 2006 (actual)
First posted: 15 Sep 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
Intervention model: Parallel groups

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 (19 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

Mean seated trough cuff DBP and SBP
Time frame: after 8 week

3 secondary outcomes

The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements
Time frame: after 8 week
The percentage of patients with uncontrolled hypertension
Time frame: after 8 weeks
Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points
Time frame: after 8 weeks

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 28 Dec 2017.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management

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 chair

Boehringer Ingelheim

113 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 19 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 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 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?

Mean seated trough cuff DBP and SBP (time frame: after 8 week). 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 NCT00168779.

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 28 Dec 2017.