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OpenTrials
Completed

NCT Number: NCT00281593

Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension

To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1236.1.601 Boehringer Ingelheim Investigational Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients >=18 years of age with Stage I or II hypertension defined as:
  • a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Exclusion criteria

  • Pregnant
  • breast-feeding
  • unwilling to use birth control during the study
  • secondary hypertension
  • SBP>=180 mmHg
  • DBP>=120 mmHg
  • severe renal dysfunction
  • hepatic insufficiency
  • stroke within the last 6 months
  • myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months
  • unstable or uncontrolled diabetes
  • history of angioedema of either of the study drugs, and hypersensitivity to the study drugs.

Treatment and study plan

Telmisartan

Drug

Ramipril

Drug

Primary outcomes

  1. Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

Secondary outcomes

  1. Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study

Important dates

Study start
2006
Primary completion
2007
First posted
Jan 25, 2006
Registry last updated
Dec 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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