Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
An Eight Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With Essential Hypertension
1 other identifier
interventional
1,613
3 countries
3
Brief Summary
This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Sep 2007
Shorter than P25 for phase_3 hypertension
3 active sites
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
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 12, 2007
CompletedFirst Posted
Study publicly available on registry
September 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
March 25, 2011
CompletedMarch 25, 2011
February 1, 2011
10 months
September 12, 2007
December 16, 2010
February 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Baseline and Week 8
Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Baseline and Week 8
Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint
Baseline and Week 8
Secondary Outcomes (3)
Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint
Baseline and Week 8
Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg
Week 8
Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP
Week 8
Study Arms (4)
Aliskiren 300 mg
EXPERIMENTALAliskiren 300 mg once daily
Aliskiren 150 mg
EXPERIMENTALAliskiren 150 mg once daily
Aliskiren 75 mg
EXPERIMENTALAliskiren 75 mg once daily
Ramipril 5 mg
ACTIVE COMPARATORRamipril 5 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have msDBP ≥ 90 mmHg and \< 110 mmHg at the visit immediately prior to Visit 3
- Patients must have msDBP \>OR= 95 mmHg and \< 110 mmHg at Visit 3
- Patients must have an absolute difference of \< or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3
You may not qualify if:
- Severe hypertension (grade 3 WHO classification; msDBP \>or= 110 mmHg and/or msSBP \>or = 180 mmHg).
- History or evidence of a secondary form of hypertension.
- History of transient ischemic cerebral attack within 12 months of visit 1.
- Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
- Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8% at Visit 1.
- Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (3)
Novartis Investigative Sites
China, China
Novartis Investigative Sites
India, India
Novartis Investigative Sites
Thailand, Thailand
Related Publications (1)
Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.
PMID: 33089502DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2007
First Posted
September 14, 2007
Study Start
September 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
March 25, 2011
Results First Posted
March 25, 2011
Record last verified: 2011-02