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Renin Inhibitor/Calcium Channel Blocker/Thiazide Diuretic

Aliskiren/Amlodipine/Hydrochlorothiazide for High Blood Pressure

Phase 3
Waitlist Available
Research Sponsored by Novartis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 28 and 54 endpoints
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 20 Other Conditions
Pivotal Trial

Summary

This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.

Eligible Conditions
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 28 and 54 endpoints
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 28 and 54 endpoints for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
Secondary study objectives
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Aliskiren/Amlodipine/HydrochlorothiazideExperimental Treatment3 Interventions
Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aliskiren
FDA approved
Amlodipine
FDA approved
Hydrochlorothiazide
FDA approved

Find a Location

Who is running the clinical trial?

NovartisLead Sponsor
1,636 Previous Clinical Trials
2,773,029 Total Patients Enrolled
~32 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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