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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00239538

NCT00239538
Completed Phase 4 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be able to read and sign a consent form agreeing to take part.
  • You must have high blood pressure, with specific readings recorded at a clinic visit (diastolic pressure between 95–109 and/or systolic pressure between 140–179).
  • You must also have high blood pressure confirmed by a 24-hour blood pressure monitor worn at home (diastolic of 85 or higher and/or systolic of 130 or higher).
  • You must be 30 years of age or older.
  • You must be able to safely stop any current blood pressure medications during the trial.
  • You must have been diagnosed with type-2 diabetes, with a blood sugar control reading (HbA1c) of 10% or below.
  • You must be overweight or obese, measured by BMI — at least 27 for non-Asian participants, or at least 24 for Asian participants.
  • If you are female, you must have a negative pregnancy test at the start of the trial.

Who may not be able to join:

  • Women who could become pregnant and are not using an acceptable form of birth control, are not surgically sterile, or are currently nursing or pregnant.
  • People who work night shifts.
  • Anyone whose blood pressure readings were very high (systolic 180 or above, or diastolic 110 or above) at any point during the early run-in phase of the trial.
  • Anyone with a known or suspected cause of high blood pressure other than primary hypertension, or who has liver or kidney problems.
  • Anyone with a fasting blood sugar level above 17 mmol/l (or 300 mg/dl) at the first clinic visit.
  • Anyone with narrowing of the arteries supplying both kidneys, narrowing in the artery of a single kidney, currently on dialysis, or who has had a kidney transplant.
  • Anyone with clinically significant low sodium, low potassium, or high potassium levels in their blood.
  • Anyone with significant dehydration or fluid loss that has not been treated.
  • Anyone diagnosed with a condition called primary aldosteronism (an adrenal gland disorder causing high blood pressure).
  • Anyone with a hereditary condition called hereditary fructose intolerance.
  • Anyone with a bile flow blockage disorder, such as cholestasis.
  • Anyone with heart failure.
  • Anyone who has had a stroke in the past six months.
  • Anyone with severe narrowing of the heart's coronary arteries (confirmed by a doctor).
  • Anyone who has had a heart attack, heart surgery, or unstable chest pain in the past three months.
  • Anyone who has had a heart procedure (percutaneous coronary intervention/PCI) in the past three months, or has one planned during the trial.
  • Anyone with ongoing serious heart rhythm problems, such as ventricular tachycardia, atrial fibrillation, or atrial flutter.
  • Anyone with certain structural heart conditions, including a thickened obstructive heart muscle, aortic valve narrowing, or significant narrowing of the aortic or mitral heart valves.
  • Anyone with type-1 diabetes.
  • Anyone who has previously experienced swelling of the face, lips, or throat (angioedema) while taking a type of blood pressure medication called an ACE inhibitor or ARB.
  • Anyone with a history of drug or alcohol dependency in the past six months.
  • Anyone regularly taking medications that are known to affect blood pressure and are not permitted by the trial.
  • Anyone who has taken part in another drug trial in the past month.
  • Anyone with a known allergy to any ingredient in the study medication.
  • Anyone currently taking corticosteroids, colestipol, or cholestyramine medications.
  • Anyone with a health condition that would make it unsafe to complete the trial.
  • Anyone who would be unable to follow the trial's requirements.
  • Anyone who has surgery planned during the trial period.
  • Anyone with a history of not taking prescribed medications as directed.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 4: approximately Approved of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 4
Sponsor
Boehringer Ingelheim
Registry
clinicaltrials_gov
Start date
1 January 2003
Est. completion
1 December 2004

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇨🇦 Canada 🇲🇽 Mexico 🇳🇿 New Zealand 🇰🇷 South Korea 🇹🇼 Taiwan 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Changes from baseline in the mean SBP and DBP as measured by ambulatory blood pressure monitoring (ABPM)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov