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Completed

NCT Number: NCT00219089

A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus

Completed

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Key information

Conditions

Hypertension, Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with essential hypertension
  • Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
  • Patients who are eligible and able to participate in the study

Exclusion criteria

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary outcomes

  1. Change from baseline to week 4 endpoint in mean sitting diastolic blood pressure

  2. Change from baseline to week 8 endpoint in mean sitting systolic blood pressure

  3. Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
May 17, 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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