NCT00208221

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 8, 2007

Status Verified

November 1, 2007

First QC Date

September 13, 2005

Last Update Submit

November 7, 2007

Conditions

HypertensionType 2 DiabetesAlbuminuria

Keywords

HypertensionDiabetesMicroalbuminuriaBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Microalbuminuria

Secondary Outcomes (7)

  • Plasma renin

  • plasma angiotensin

  • plasma aldosterone

  • plasma catecholamines

  • oxydative stress

  • +2 more secondary outcomes

Interventions

ramiprilDRUG
ramipril-telmisartanDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherches Cliniques de Montreal

Montreal, Quebec, J4X 1J3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 38682786DERIVED

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2AlbuminuriaDiabetes Mellitus

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pierre Larochelle, MD PhD FRCPC

    Institut de Recherches Cliniques de Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 2006

Study Completion

June 1, 2007

Last Updated

November 8, 2007

Record last verified: 2007-11

Locations

CA(1)