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HypertensionPhase 3NCT00208221

Higher Dose of Ramipril Versus Addition of Telmisartan-Ramipril in Hypertension and Diabetes

A Phase 3 study testing ramipril and ramipril-telmisartan in people with Hypertension and Type 2 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if a dose of ramipril combined with a normal dose of telmisartan 80 mg will be more effective than ramipril 20 mg in reducing microalbuminuria in hypertensive patients with diabetes. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension, Type 2 Diabetes, Albuminuria
What is being tested?
ramipril and ramipril-telmisartan
How many people
50 participants
Where
1 siteCanada
Study dates
Aug 2006to Jun 2007
Phase
Phase 3
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female over the age of 18 years
  • Diastolic blood pressure (DBP) greater tha 80 mmHg and less than 104 mmHg
  • Type II diabetes on diet or oral hypoglycemic agents with a hemoglobin A1C (HbA1C) less than 0.080
  • UA ratio albumin:creatinine 2.0 to 25 mg/mmol

Who cannot join

  • DBP > 104 mmhg
  • Woman not surgically sterile or menopausal.
  • Premenopausal women whoo are not surgically sterile or who are not practicing acceptable means of birth control and do not agree to submit to periodic pregnancy tests.
  • Known or secondary forms of hypertension.
  • Intolerance to angiotensin (AT) 1 receptor blockers or angiotensin-converting enzyme (ACE) inhibitors.
  • Hepatic or renal dysfunction. Creatinine > 150 umol or enzymes greater than 2 times upper limit of normal.
Show all 29Show fewer
  • Hemodynamically significant renal artery stenosis, renal artery stenosis on a solitary kidney, post-renal transplant or with only one kidney.
  • Uncorrected volume depletion.
  • Biliary obstructive disorders.
  • NYHA functional class congestive heart failure (CHF) III-IV.
  • Coronary heart disease needing pharmacological therapy.
  • Stroke within the preceding six months.
  • Percutaneous transluminal coronary angioplasty (PTCA) within the preceding three months.
  • History of angioedema.
  • Sustained ventricular tachycardia, atrial fibrillation, or other clinically relevant cardiac arrhythmias as determined by the clinical investigator.
  • Second or third degree AV block, left bundle branch block or any clinically relevant conduction abnormality as determined by the clinical investigator.
  • Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
  • Administration of digoxin.
  • Patients with a fasting glucose greater than 7.0
  • History of drug or alcohol dependency.
  • Use of antihypertensive agents such as diuretics, ACE inhibitors, angiotensin II antagonists, alpha-blockers, beta-blockers, calcium channel antagonists, direct vasodilators that cannot be stopped for the trial.
  • Administration of other non-antihypertensive medications known to affect blood pressure (e.g. oral corticosteroids, monoamine oxidase [MAO] inhibitors, nitrates) at any time during the trial.
  • Chronic use of salt substitutes containing potassium chloride; potassium supplements; extreme dietary restrictions.
  • Uncorrected sodium depletion as defined by a serum sodium level less than 135 mEq/L.
  • Clinically significant hyperkalemia as defined by serum potassium level greater than 5.2 mEq/L. Clinically significant hypokalemia as defined by serum potassium level less than 3.0 mEq/L.
  • Patients receiving any investigational therapy within one month of signing the informed consent form.
  • Known hypersensitivity to any component of telmisartan, ramipril or hydrochlorothiazide.
  • Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication.
  • Blood donation in the preceding 1 month.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut de Recherches Cliniques de Montreal

    Montreal, Quebec, J4X 1J3

Other trials in Canada

About this study

Official title: Comparison of a Higher Dose of Ramipril to the Addition of Telmisartan 80 mg+Ramipril 10 mg in Patients With Hypertension and Diabetes

The purpose of this study is to determine if a dose of ramipril combined with a normal dose of telmisartan 80 mg will be more effective than ramipril 20 mg in reducing microalbuminuria in hypertensive patients with diabetes.

Read the detailed description

The purpose of this study is to determine the effects of ramipril 10 mg and telmisartan 80 mg versus ramipril 20 mg in patients with diabetes type II, hypertension and microalbuminuria (Urinary-albuminuria creatinine ratio of 2.0 to 25 mg/mmol) on

  1. Microalbuminuria
  2. Blood pressure (systolic, diastolic and ABPM), Renin-angiotensin system, Catecholamines, Oxydative stress
  3. Comparison at 4, 8 and 12 weeks with addition of hydrochlorothiazide 12.5 mg if BP over 130/80 mmHg
Being tested
ramipril, ramipril-telmisartan
Keywords
Hypertension, Diabetes, Microalbuminuria, Blood pressure
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2, Albuminuria, Diabetes Mellitus

What participants receive

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

  • ramiprilDrug

  • ramipril-telmisartanDrug

What is being measured

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

  1. Microalbuminuria

Secondary outcomes (7)

  1. Plasma renin

  2. plasma angiotensin

  3. plasma aldosterone

  4. plasma catecholamines

  5. oxydative stress

  6. diastolic blood pressure

  7. systolic blood pressure

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startAug 2006
  3. Study completionJun 2007

Why it stopped: Not enough recruitment

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00208221
Sponsor's protocol ID
RD 0507/17259
Status last verified
Nov 2007
First submitted
13 Sep 2005
Last updated
8 Nov 2007
Results posted
No
Data monitoring committee
No

Publications

  • Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

    PubMed 38682786

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ramipril and ramipril-telmisartan in people with Hypertension and Type 2 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

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 29 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: stopped early, as of the sponsor's last update on 8 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Not enough recruitment). Results are not available in the source record.

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?

Microalbuminuria. 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 NCT00208221, 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 2007.

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