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ObesityPhase 4NCT00775814

Efficacy of Candesartan on Reducing Blood Pressure in Insulin-Resistant, Obese Patients With Hypertension.

A Phase 4 study testing Candesartan and Hydrochlorothiazide and Hydrochlorothiazide (HCT) in people with Obesity and Hypertension, run by Takeda at 24 sites in Germany.

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 purpose of this study is to determine the efficacy of candesartan, once daily (QD), combined with hydrochlorothiazide to lower blood pressure in insulin-resistant, obese patients with hypertension. Read more about this study

Who is it for?
Ages 35 to 70 years
Conditions the study is for
Obesity, Hypertension
What is being tested?
Candesartan and Hydrochlorothiazide and Hydrochlorothiazide (HCT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
24 sitesGermany
Study dates
Oct 2006to Sep 2008
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 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has an Abdominal obesity with a waist circumference greater than 102 cm (men) and greater than 88 cm (women).
  • Has a body mass index greater than 30 kg/m^2.
  • Has hypertension not adequately controlled (seated diastolic blood pressure greater than 95 mmHg and less than or equal to 110 mmHg as median value of three readings) by monotherapy with either beta-blocker or calcium channel blocker.
  • Has a Homeostasis Model Assessment Insulin Resistance index greater than 3.99.
  • Has hyperlipidemia with fasting levels for total cholesterol greater than 250 mg/dL (6.45 mmol/L) or low-density lipoprotein cholesterol greater than 160 mg/dL (4.13 mmol/L) or triglycerides greater than 250 mg/dL (2.82 mmol/L).

Who cannot join

  • Existing Hydrochlorothiazide therapy at start of study.
  • Diabetes mellitus type 1 or 2 [known or newly detected (Screening: fasting plasma glucose greater than 7.0 mmol/L)].
  • Chronic renal impairment or S-creatinine greater than or equal to 1.8 mg/dL.
  • Presence of single kidney or state after kidney transplantation or known bilateral renal artery stenosis or interventional treatment for renal artery stenosis in the last year.
  • Hyperkalemia (potassium greater than 5.5 mmol/L).
  • Known electrolyte imbalance, e.g. hypocalcaemia or hypokalemia resistant to treatment.
Show all 27Show fewer
  • Nephrotic syndrome.
  • Thyroid dysfunction.
  • Primary or secondary hyperaldosteronism.
  • Cushing syndrome.
  • Known or suspected familial hypercholesterolemia.
  • Severe hepatic impairment (cholestasis (bilirubin greater than 2.0 mg/dL) or alanine aminotransferase and/or aspartate aminotransferase greater than 3 times the upper limit of normal and/or γ-glutamyl transpeptidase greater than 5 times the upper limit of normal).
  • History of chronic heart failure.
  • History of overt coronary heart disease.
  • History of silent myocardial infarction.
  • Hemodynamically relevant stenosis of the mitral and/or aortic valve.
  • History of stroke.
  • Stage 3 hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg).
  • Angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy in the previous 4 weeks.
  • Lipid-lowering therapy with cholesterol synthesis enzyme inhibitors or anticipated initiation of such a therapy.
  • History of autoimmune disease.
  • History of cancer in the last 5 years or wasting disease.
  • Intake of prohibited concomitant medication.
  • Has known hypersensitivity/allergy to the study drugs.
  • Has drug addiction and/or extensive use of alcohol.
  • Psychological and/or emotional problems which would render the informed consent invalid or limit the ability of the patient to comply with the study requirements.
  • Participation in a clinical investigation within 30 days prior to enrolment in this trial.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Germany24 sites

  • Study site

    Bad Dürrheim, Baden-Wurttemberg

  • Study site

    Bad Segeberg, Schleswig-Holstein

  • Study site

    Balingen, Baden-Wurttemberg

  • Study site

    Berlin, State of Berlin

  • Study site

    Bocholt, North Rhine-Westphalia

  • Study site

    Cologne, North Rhine-Westphalia

  • Study site

    Deggingen, Baden-Wurttemberg

  • Study site

    Dresden, Saxony

  • Study site

    Essen, North Rhine-Westphalia

  • Study site

    Freital, Saxony

  • Study site

    Ingolstadt, Bavaria

  • Study site

    Isselburg, North Rhine-Westphalia

  • Study site

    Machem, Saxony

  • Study site

    Markkleeberg, Saxony

  • Study site

    München, Bavaria

  • Study site

    Passau, Bavaria

  • Study site

    Rödersheim-Gronau, Rhineland-Palatinate

  • Study site

    Roetgen, North Rhine-Westphalia

  • Study site

    Rottweil, Baden-Wurttemberg

  • Study site

    Schauenburg, Hesse

  • Study site

    Spaichingen, Baden-Wurttemberg

  • Study site

    Troisdorf, North Rhine-Westphalia

  • Study site

    Wermsdorf, Saxony

  • Study site

    Wesseling, North Rhine-Westphalia

Other trials in Germany

About this study

Official title: Double-blind, Randomized Trial to Investigate the Antihypertensive and Metabolic Effects of Candesartan in Insulin-resistant Obese Patients With a Hypertension Not Adequately Controlled by Previous ß-blocker or Calcium Channel Blocker

The purpose of this study is to determine the efficacy of candesartan, once daily (QD), combined with hydrochlorothiazide to lower blood pressure in insulin-resistant, obese patients with hypertension.

Read the detailed description

Abdominal obesity is a major risk factor for insulin resistance and the development of type 2 diabetes. It is associated with sodium retention, left ventricular hypertrophy and elevated markers of inflammation and is an important predictor of cardiovascular morbidity and mortality. Activation of the sympathetic nervous system and the renin angiotensin aldosterone system are both involved in the development of hypertension in obese individuals. Hypertension in obese individuals is often associated with dyslipidemia, hyperinsulinaemia and impaired glucose tolerance.

In order to decrease the cardiovascular risk of obese hypertensive patients, therapy should not only be directed to lowering blood pressure values but also to improvement of their metabolic situation. As it is possible that antihypertensive treatment based on an angiotensin receptor antagonist (like candesartan) might be superior to beta-blocker or calcium channel blocker therapy in preventing diabetes, a combination of candesartan with already existing insufficiently effective beta-blocker or calcium channel blocker therapy will be used in this study.

Being tested
Candesartan and Hydrochlorothiazide, Hydrochlorothiazide (HCT)
Keywords
Hypertension, Drug Therapy, Blood Pressure, Insulin, Resistant
Medical subject headings
Obesity, Hypertension, Insulin Resistance

What participants receive

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

  • Candesartan and HydrochlorothiazideDrug

    Also called BLOPRESS PLUS®

    Candesartan 8 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for 2 weeks; increased to Candesartan 16 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.

  • Hydrochlorothiazide (HCT)Drug

    Candesartan placebo-matching tablets and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 24 weeks.

Study groups in NCT00775814
Study groupRoleWhat they receive
Candesartan + Hydrochlorothiazide QDExperimentalNot described
Receives: Drug: Candesartan and Hydrochlorothiazide
Hydrochlorothiazide QDActive comparatorNot described
Receives: Drug: Hydrochlorothiazide (HCT)

What is being measured

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

  1. The change from Baseline in Blood pressure (mean reduction in Diastolic Blood Pressure measured at trough).

    Measured: End of Treatment

Secondary outcomes (11)

  1. The change from Baseline in Adiponectin.

    Measured: At Final Visit.

  2. The change from Baseline in high sensitivity C-Reactive Protein.

    Measured: At Final Visit.

  3. The change from Baseline in Fasting Plasma Glucose.

    Measured: At Final Visit.

  4. The change from Baseline in Fasting Plasma Insulin.

    Measured: At Final Visit.

  5. The change from Baseline in Insulin Resistance (assessed by Homeostasis Model Assessment Insulin Resistance).

    Measured: At Final Visit.

  6. The change from Baseline in Lipid Parameters (total cholesterol, low-density lipoprotein cholesterol, high density lipoprotein cholesterol and triglycerides).

    Measured: At Final Visit.

  7. The change from Baseline in Fibrinogen.

    Measured: At Final Visit.

  8. The change from Baseline in Prospective Cardiovascular Münster risk score for the assessment of coronary heart disease.

    Measured: At Final Visit.

  9. The change from Baseline in 24-hour mean blood pressure as assessed by Ambulatory Blood Pressure Measurement.

    Measured: At Final Visit.

  10. The change from Baseline in Daytime and night-time mean blood pressure Ambulatory Blood Pressure Measurement.

    Measured: At Final Visit.

  11. The change from Baseline in Systolic Blood Pressure.

    Measured: End of Treatment.

Timeline

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

  1. First posted20 Oct 2008 (estimated)
  2. Study startOct 2006
  3. Primary completionSep 2008
  4. Study completionSep 2008

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00775814
Sponsor's protocol ID
BLO K025
Other IDs
2006-001998-25, D-CAN-545, U1111-1113-9336
Status last verified
Aug 2012
First submitted
16 Oct 2008
Last updated
8 Aug 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Candesartan and Hydrochlorothiazide and Hydrochlorothiazide (HCT) in people with Obesity and Hypertension, run by Takeda at 24 sites in Germany.

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 5 inclusion and 27 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 Aug 2012. 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 Germany. 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?

The change from Baseline in Blood pressure (mean reduction in Diastolic Blood Pressure measured at trough). (time frame: End of Treatment). 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 NCT00775814.

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 Aug 2012.

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