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HypertensionPhase 2NCT00153049

3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension

A Phase 2 study testing Telmisartan, Hydrochlorothiazide and Telmisartan + Hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim at 24 sites in Japan.

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

1. To investigate the dose response of the combination therapy, Telmisartan and Hydrochlorothiazide for the Japanese patients with Essential Hypertension. 2. To compare this dose response with that in the US study. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Hypertension
What is being tested?
Telmisartan, Hydrochlorothiazide and Telmisartan + Hydrochlorothiazide
How many people
583 participants
Where
24 sitesJapan
Study dates
Jun 2004to Jun 2005
Phase
Phase 2
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Essential hypertensive patients who meet the following criteria:
  • Mean supine DBP >= 95 and <= 114 mm Hg at each of Visits 2 and 3.
  • Mean supine DBP must not vary by more than 10 mm Hg between Visit 2 and Visit 3.
  • Mean supine systolic blood pressure (SBP) must be >= 140 and <= 200 mm Hg at Visit 3.
  • (The mean DBP and SBP values are calculated as the mean of the three supine measurements taken two minutes apart.)
  • Male or female.
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  • Age >= 20 and Age <= 80 years.
  • Outpatient.
  • Able to stop current antihypertensive therapy without risk to the patient.
  • Ability to provide written Informed Consent in accordance with ?Good Clinical Practice (GCP)? (MHW Ordinance No. 28, as of Mar. 27, 1997) and the local legislation.

Who cannot join

  • Known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, melanocytoma, etc.).
  • Mean supine DBP > 114 mmHg and/or mean supine SBP > 200 mmHg during any visit of the placebo run-in period.
  • Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias (atrioventricular conduction disturbance (grade II - III), atrial fibrillation etc.).
  • NYHA functional class heart failure III-IV.
  • Myocardial infarction or cardiac surgery within 6 months of signing the informed consent form.
  • Coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA) within 3 months of signing the informed consent form.
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  • Unstable angina within 3 months of signing the informed consent form.
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
  • Stroke or transient ischemic attack within 6 months of signing the informed consent form.
  • History of sudden exacerbation of renal function with AT1 receptor antagonists or ACE inhibitors; post-renal transplant.
  • Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, laryngeal swelling with dyspnea) during treatment with AT1 receptor antagonists or ACE inhibitors.
  • Known hypersensitivity to any component of the formulation, or a known hypersensitivity to sulfonamides or sulphonamide-derived drugs (e.g. thiazides).
  • Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
  • SGPT(ALT) or SGOT(AST) >= 2 times the upper limit of normal at screening (Visit 1).
  • Patients who have markedly poor bile secretion by the following laboratory parameters: Patients whose direct bilirubin >= 2.0 mg/dL at screening (Visit 1).
  • Serum creatinine >= 2.1 mg/dL at screening (Visit 1).

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Japan24 sites

  • Boehringer Ingelheim Investigational Site

    Annaka, Gunma, 379-0016

  • Boehringer Ingelheim Investigational Site

    Asahi,Chiba, 289-2151

  • Boehringer Ingelheim Investigational Site

    Fukuoka, Fukuoka, 814-0163

  • Boehringer Ingelheim Investigational Site

    Fukuoka, Fukuoka, 819-8551

  • Boehringer Ingelheim Investigational Site

    Ichinomiya, Aichi, 491-0851

  • Boehringer Ingelheim Investigational Site

    Iida,Nagano, 395-8558

  • Boehringer Ingelheim Investigational Site

    Inzai, Chiba, 270-1347

  • Boehringer Ingelheim Investigational Site

    Isesaki, Gunma, 372-0001

  • Boehringer Ingelheim Investigational Site

    Kako-gun, Hyogo, 675-1112

  • Boehringer Ingelheim Investigational Site

    Kasuya-gun,Fukuoka, 811-2311

  • Boehringer Ingelheim Investigational Site

    Katsushika-ku,Tokyo, 124-0006

  • Boehringer Ingelheim Investigational Site

    Kobe, Hyogo, 651-0072

  • Boehringer Ingelheim Investigational Site

    Koshigaya, Saitama, 343-0856

  • Boehringer Ingelheim Investigational Site

    Mono-gun, Miyagi, 981-0503

  • Boehringer Ingelheim Investigational Site

    Osaka, Osaka, 530-0001

  • Boehringer Ingelheim Investigational Site

    Osaka, Osaka, 550-0014

  • Boehringer Ingelheim Investigational Site

    Sendai, Miyagi, 980-8660

  • Boehringer Ingelheim Investigational Site

    Setagun, Gunma, 377-0061

  • Boehringer Ingelheim Investigational Site

    Shinjyuku, Tokyo, 160-0022

  • Boehringer Ingelheim Investigational Site

    Shiroishi, Miyagi, 989-0228

  • Boehringer Ingelheim Investigational Site

    Shiroishi, Miyagi, 989-0231

  • Boehringer Ingelheim Investigational Site

    Suita, Osaka, 565-0853

  • Boehringer Ingelheim Investigational Site

    Takasaki, Gunma, 370-0811

  • Boehringer Ingelheim Investigational Site

    Taya-gun, Gunma, 370-2132

Other trials in Japan

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, 3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension

  1. To investigate the dose response of the combination therapy, Telmisartan and Hydrochlorothiazide for the Japanese patients with Essential Hypertension.
  2. To compare this dose response with that in the US study.
Read the detailed description

This is an 8-week multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group study utilizing all cells of a 3 x 3 factorial design. Following Screening examinations and a 4-week Placebo Run-In Period, 540 patients will be randomized to receive once-daily monotherapy with either telmisartan (MICARDIS), hydrochlorothiazide, placebo, or combination therapy with telmisartan and hydrochlorothiazide for 8 weeks (Treatment Period).

This study includes nine cells, placebo, telmisartan (TEL) 40 mg, TEL 80 mg, hydrochlorothiazide (HCTZ) 6.25 mg, HCTZ 12.5 mg, TEL 40 mg/HCTZ 6.25 mg, TEL 40 mg/HCTZ 12.5 mg, TEL 80 mg/HCTZ 6.25 mg, and TEL 80 mg/HCTZ 12.5 mg.

Study Hypothesis:

The hypothesis is that the dose response model for the Japanese patient with essential hypertension which is constructed for the change of the supine diastolic blood pressure from the baseline value to end of treatment with the multiple regression analysis, is similar to that in the US study 502.204.

Comparison(s):

The primary efficacy parameter will be the change from baseline in supine diastolic blood pressure at trough (24 hours post-dose) at the last visit during the Double-Blind Period.

The dose response surface model will be constructed. The graphs of dose response surface will be generated based on the final model. The model in this study will compare with that in US study from the perspective of including the same terms in the model.

Conditions
Hypertension
Being tested
Telmisartan, Hydrochlorothiazide, Telmisartan + Hydrochlorothiazide
Medical subject headings
Hypertension

What participants receive

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

  • TelmisartanDrug

  • HydrochlorothiazideDrug

  • Telmisartan + HydrochlorothiazideDrug

What is being measured

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

  1. Change from baseline in supine diastolic blood pressure (DBP) at trough (24 hours post-dose)

    Measured: after 8 weeks

Secondary outcomes (6)

  1. Change in supine systolic blood pressure (SBP) at trough (24 hours post-dose)

    Measured: after 8 weeks

  2. Change in sitting systolic and diastolic blood pressure at trough (24 hours post-dose)

    Measured: after 8 weeks

  3. DBP control rate

    Measured: after 8 weeks

  4. DBP response rate

    Measured: after 8 weeks

  5. SBP response rate

    Measured: after 8 weeks

  6. Incidence of adverse events

    Measured: up to 8 weeks

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionJun 2005
  4. Study completionJun 2005

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
583 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00153049
Sponsor's protocol ID
502.439
Status last verified
Nov 2013
First submitted
9 Sep 2005
Last updated
8 Nov 2013
Results posted
No

Publications

  • Horie Y, Higaki J, Takeuchi M. Design, statistical analysis and sample size calculation of dose response study of telmisartan and hydrochlorothiazide. Contemp Clin Trials. 2007 Sep;28(5):647-53. doi: 10.1016/j.cct.2007.02.005. Epub 2007 Feb 27.

    PubMed 17389151

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telmisartan, Hydrochlorothiazide and Telmisartan + Hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim at 24 sites in Japan.

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 10 inclusion and 16 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 8 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 24 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 supine diastolic blood pressure (DBP) at trough (24 hours post-dose) (time frame: after 8 weeks). 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 NCT00153049, which also lists 1 linked publication.

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 8 Nov 2013.

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