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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00281593

Enrollment

1354

Registered

2006-01-25

Start date

2006-04-30

Completion date

Unknown

Last updated

2017-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

Interventions

DRUGTelmisartan

DRUGRamipril

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment	—

Secondary

Measure	Time frame
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	—

Countries

Argentina, Canada, Chile, Mexico, Peru, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026