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Aliskiren+HCTZ+amlodipine - Phase 3
This triple-combination drug lowers blood pressure by blocking the renin-angiotensin system (aliskiren), reducing fluid volume (HCTZ), and relaxing blood vessels (amlodipine).
This triple-combination drug lowers blood pressure by blocking the renin-angiotensin system (aliskiren), reducing fluid volume (HCTZ), and relaxing blood vessels (amlodipine). Used for Hypertension (high blood pressure).
At a glance
| Generic name | Aliskiren+HCTZ+amlodipine - Phase 3 |
|---|---|
| Sponsor | Novartis |
| Drug class | Antihypertensive combination (renin inhibitor + thiazide diuretic + calcium channel blocker) |
| Target | Renin (aliskiren component); sodium-potassium-chloride cotransporter (HCTZ component); L-type calcium channels (amlodipine component) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Aliskiren is a direct renin inhibitor that blocks the first step of the renin-angiotensin-aldosterone system. Hydrochlorothiazide (HCTZ) is a thiazide diuretic that reduces blood volume and sodium reabsorption. Amlodipine is a calcium channel blocker that causes vasodilation. Together, these three agents provide complementary antihypertensive effects targeting different pathways of blood pressure regulation.
Approved indications
- Hypertension (high blood pressure)
Common side effects
- Dizziness
- Fatigue
- Hyperkalemia (elevated potassium)
- Hypotension
- Peripheral edema
- Cough
Key clinical trials
- Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II Hypertension (PHASE4)
- Aliskiren Study of Safety and Efficacy in Senior Hypertensives (PHASE4)
- Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aliskiren+HCTZ+amlodipine - Phase 3 CI brief — competitive landscape report
- Aliskiren+HCTZ+amlodipine - Phase 3 updates RSS · CI watch RSS
- Novartis portfolio CI