| Tekturna (aliskiren) / PDL |
NCT00219024 / 2004-000240-25: Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension. |
|
|
| Completed | 3 | 2775 | US, Europe | aliskiren | Novartis | Hypertension | 06/05 | 06/05 | | |
NCT00219128: A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure. |
|
|
| Completed | 3 | 671 | US | aliskiren | Novartis | Hypertension | 06/05 | 06/05 | | |
NCT00219089 / 2004-001062-40: A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients. |
|
|
| Completed | 3 | 839 | US, Europe | aliskiren | Novartis | Hypertension, Diabetes Mellitus | 08/05 | 08/05 | | |
NCT00219037: Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension |
|
|
| Completed | 3 | 1955 | Europe | aliskiren | Novartis | Hypertension | 10/05 | 10/05 | | |
NCT00219076 / 2004-002410-11: A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients |
|
|
| Completed | 3 | 504 | US, Europe | aliskiren | Novartis | Hypertension | 10/05 | | | |
NCT00219050 / 2004-001060-50: A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension |
|
|
| Completed | 3 | 180 | Europe | aliskiren | Novartis | Hypertension | 11/05 | 11/05 | | |
NCT00219154 / 2004-004015-38: A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazidebased Treatment Regimen With Optional Addition of Amlodipine |
|
|
| Completed | 3 | 1125 | Europe | aliskiren | Novartis | Hypertension | 01/06 | 01/06 | | |
| Completed | 3 | 355 | Europe | aliskiren | Novartis | Hypertension | 02/06 | 02/06 | | |
NCT00171405: A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg |
|
|
| Completed | 3 | 250 | US, Canada, Europe, RoW | aliskiren | Novartis | Hypertension | 02/06 | 02/06 | | |
NCT00219115 / 2004-003905-26: A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg |
|
|
| Completed | 3 | 493 | US, Europe | aliskiren | Novartis | Hypertension | 03/06 | 03/06 | | |
NCT00219063 / 2004-001061-17: A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal. |
|
|
| Completed | 3 | 844 | US | aliskiren | Novartis | Hypertension | 03/06 | 03/06 | | |
NCT00294710: A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine |
|
|
| Completed | 3 | 976 | US, Europe | Aliskiren | Novartis | Hypertension | 07/06 | 07/06 | | |
| Completed | 3 | 693 | Europe | Aliskiren | Novartis | Hypertension | 08/06 | 08/06 | | |
NCT00219180 / 2005-000039-73: Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure |
|
|
| Completed | 3 | 1797 | US, Europe | aliskiren | Novartis | Hypertension | 09/06 | 09/06 | | |
NCT00260923: A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure |
|
|
| Completed | 3 | 641 | US, Europe | aliskiren | Novartis | Hypertension | 11/06 | 11/06 | | |
NCT00299806: SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension |
|
|
| Completed | 3 | 39 | Japan | Aliskiren | Novartis | Hypertension | 11/06 | 11/06 | | |
NCT00219193 / 2005-002635-27: A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients |
|
|
| Completed | 3 | 641 | US, Europe | aliskiren | Novartis | Hypertension | 01/07 | 01/07 | | |
NCT00343551 / 2005-004993-26: Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension. |
|
|
| Completed | 3 | 654 | Europe | Aliskiren | Novartis | Essential Hypertension | 01/07 | | | |
NCT00344110: Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension |
|
|
| Completed | 3 | 768 | Japan | Aliskiren | Novartis | Hypertension | 04/07 | 04/07 | | |
NCT00219102 / 2004-004794-28: A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients |
|
|
| Completed | 3 | 336 | Europe, US, RoW | aliskiren | Novartis | Hypertension, Diabetes | 05/07 | 05/07 | | |
NCT00299832: SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction |
|
|
| Completed | 3 | 40 | Japan | Aliskiren | Novartis | Hypertension | 05/07 | 05/07 | | |
NCT00386139 / 2005-004579-39: A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients |
|
|
| Completed | 3 | 881 | US, Europe | Aliskiren/HCTZ | Novartis | Hypertension | 07/07 | 07/07 | | |
NCT00518765: Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet |
|
|
| Completed | 3 | 32 | US | Aliskiren, SPP100, Aliskiren plus placebo | Novartis | Hypertension | 08/07 | | | |
NCT00387517 / 2005-004580-40: Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension |
|
|
| Completed | 3 | 726 | US, Europe | Aliskiren/HCTZ | Novartis | Hypertension | 08/07 | 08/07 | | |
ALLAY, NCT00219141 / 2005-000856-34: Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension |
|
|
| Completed | 3 | 460 | US, Europe, RoW | Aliskiren 150/300 mg, Losartan 50/100 mg, Aliskiren placebo, Losartan 50/100 mg placebo | Novartis Pharmaceuticals | Hypertension, Left Ventricular Hypertrophy, Overweight | 11/07 | 11/07 | | |
NCT00368277: A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly |
|
|
| Completed | 3 | 901 | US | Aliskiren, Ramipril, Hydrochlorothiazide, Amlodipine | Novartis Pharmaceuticals | Hypertension | 02/08 | 02/08 | | |
NCT00402103: An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure |
|
|
| Completed | 3 | 556 | US, Europe, RoW | Aliskiren, Amlodipine, Hydrochlorothiazide | Novartis | Hypertension | 04/08 | 04/08 | | |
NCT00386607: A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide. |
|
|
| Completed | 3 | 601 | US, Canada, Europe | Aliskiren, Valsartan, Hydrochlorothiazide (HCTZ) | Novartis | Hypertension | 07/08 | 07/08 | | |
NCT00529451: Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg |
|
|
| Completed | 3 | 1613 | RoW | Aliskiren, Ramipril | Novartis | Hypertension | 07/08 | 07/08 | | |
NCT00706134 / 2008-001305-42: Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study |
|
|
| Completed | 3 | 756 | Europe, RoW | Placebo, Aliskiren 75 mg, Aliskiren 150 mg, Aliskiren 300 mg | Novartis | Hypertension | 04/09 | 04/09 | | |
ACQUIRE, NCT00705575 / 2008-000862-21: Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension |
|
|
| Completed | 3 | 688 | US, Europe, RoW | Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg), Aliskiren (300 mg) | Novartis | Hypertension | 04/09 | 04/09 | | |
NCT00739973: Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension |
|
|
| Completed | 3 | 2694 | US, Canada, Europe, RoW | Placebo, Aliskiren 150 mg tablet, Aliskiren 300 mg tablet, Amlodipine 5 mg capsule, Amlodipine 10 mg capsule, Aliskiren/amlodipine 150/5 mg tablet, Aliskiren/amlodipine 150/10 mg tablet, Aliskiren/amlodipine 300/5 mg tablet, Aliskiren/amlodipine 300/10 mg tablet | Novartis Pharmaceuticals | Hypertension | 05/09 | 05/09 | | |
NCT00777946 / 2006-006066-42: Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone |
|
|
| Completed | 3 | 818 | Europe, RoW | Aliskiren 300 mg, Aliskiren/Amlodipine 300/5 mg, Aliskiren/Amlodipine 300/10 mg, Placebo to Aliskiren, Placebo to Aliskiren/Amlodipine | Novartis | Hypertension | 05/09 | 05/09 | | |
2008-004242-83: A randomized, 32 week double-blind, parallel-group, multicenter study to compare the efficacy and safety of initiating treatment with combination (aliskiren/amlodipine) therapy in comparison with the sequential add-on treatment strategies in patients with essential hypertension. |
|
|
| Completed | 3 | 1236 | Europe, RoW | Hydrochlorothiazide 12.5 mg capsules, Film-coated tablet, Capsule, hard, Rasilez, Norvasc | Novartis Pharma Services AG | hypertension | | | | |
NCT00778921 / 2006-006068-44: Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone |
|
|
| Completed | 3 | 847 | Europe, RoW | Amlodipine 10 mg, Aliskiren 150, Amlodipine 300 | Novartis | Hypertension | 06/09 | 06/09 | | |
| Completed | 3 | 1191 | US, Canada, Europe, RoW | Aliskiren, Amlodipine, Hydrochlorothiazide (HCTZ), Placebo | Novartis | Hypertension | 08/09 | 08/09 | | |
| Completed | 3 | 186 | Europe | Candesartan+HCTZ - Phase 1, Aliskiren+HCTZ - Phase 2, Aliskiren+HCTZ+amlodipine - Phase 3 | Novartis | Hypertension | 08/09 | 08/09 | | |
NCT00841672 / 2008-005216-40: Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension |
|
|
| Completed | 3 | 485 | Europe, RoW | Aliskiren/amlodipine 300/10 mg tablet, Amlodipine 10 mg capsule | Novartis | Moderate to Severe Hypertension | 09/09 | 09/09 | | |
NCT00667719 / 2008-001242-10: A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension |
|
|
| Completed | 3 | 564 | Europe, US, RoW | Aliskiren, Amlodipine, Hydrochlorothiazide | Novartis | Essential Hypertension | 10/09 | 10/09 | | |
| Completed | 3 | 347 | Europe | Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ | Novartis | Essential Hypertension | 10/10 | | | |
ACCELERATE, NCT00797862: Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension |
|
|
| Completed | 3 | 1254 | Canada, Europe, RoW | Amlodipine, Norvasc, hydrochlorothiazide, Esidrix, HydroDIURIL, Oretic, Ezide, Hydro-Par, Aliskiren, SPA 100 | Novartis | Hypertension | 11/10 | 11/10 | | |
NCT01237223: Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension |
|
|
| Completed | 3 | 1342 | Japan | Aliskiren/Amlodipine 150/2.5 mg, Aliskiren/amlodipine 150/5 mg, Aliskiren 150 mg, Amlodipine 2.5 mg, Placebo of Aliskiren, Placebo of Amlodipine, Placebo of Aliskiren/amlodipine 150/2.5 mg, Placebo of Aliskiren/amlodipine 150/5 mg | Novartis | Essential Hypertension | 05/11 | 05/11 | | |
NCT01237873: Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension |
|
|
| Completed | 3 | 150 | Japan | Ali/Amlo 150/2.5 mg | Novartis Pharmaceuticals | Essential Hypertension | 02/12 | 02/12 | | |
| Completed | 3 | 56 | Europe | Aliskiren, Rasilez, Placebo | University of Erlangen-Nürnberg Medical School | Arterial Hypertension | 06/13 | 06/13 | | |
| Completed | 3 | 267 | US, Europe, RoW | Aliskiren (6.25/12.5/25 mg), Aliskiren (37.5/75/150 mg), Aliskiren (150/300/600 mg) | Novartis Pharmaceuticals | Hypertension | 08/14 | 08/14 | | |
NCT01151410 / 2009-017029-20: An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age |
|
|
| Completed | 3 | 208 | US, Europe, RoW | Aliskiren, Enalapril | Novartis Pharmaceuticals | Hypertension | 08/15 | 08/15 | | |
2006-003629-98: A 54-week, randomized, open-label, multicenter study to assess the long-term safety and tolerability of the combination of aliskiren 300 mg/ amlodipine 10 mg in patients with essential hypertension |
|
|
| Completed | 3 | 100 | Europe, RoW | Aliskiren, Amlodipine, Hydrochlorothiazide, SPP100, Norvasc 5mg, Esidrex, Norvasc 5mg, Esidrex | Novartis Pharma AG, Novartis Pharma Services AG | Hypertension | | 03/08 | | |
2008-001306-16: A 2 year extension to a 36-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-acute myocardial infarction patients when added to optimized standard therapy |
|
|
| | 3 | 100 | Europe | Rasilez, SPP100A, Rasilez, Rasilez | Novartis Pharma Services AG, Novartis Farmacéutica S.A., NOVARTIS FARMA | Essential Hypertension | | 07/11 | | |
2008-001609-40: An 8-week double-blind, multicenter, randomized, multifactorial, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren administered alone and in combination with amlodipine in patients with essential hypertension. |
|
|
| | 3 | 150 | Europe | Rasilez, Norvasc, SPA100, Rasilez, Norvasc, Rasilez, Norvasc | Novartis Pharma Services AG, Novartis Farmacéutica, S.A., NOVARTIS FARMA | hypertension | | 05/09 | | |
2007-005401-22: Effect of Aliskiren on Muscle Sympathetic Nerve Activity in hypertensive patients with chronic kidney disease |
|
|
| Ongoing | 3 | 20 | Europe | Aliskiren (Rasilez), ATC-code: C09XA02, | University Medical Center Utrecht | Hypertension and chronic kidney disease | | | | |
2010-021987-13: Renal Hemodynamic Effects of ALiskiren (rasilez) in comparison to ramipril (Tritrace) in patients with overweigHt/obeSiTy and UntreateD hYpertension: The renal HEALTH-STUDY |
|
|
| Ongoing | 3 | 16 | Europe | Rasilez, tritace, EU/1/07/405/011-020, RVG 13297, aliskiren, ramipril, aliskiren, ramipril | University Medical Center Groningen | Glomerular hypertension | | | | |
2010-020433-13: Eine 8-wöchige, monozentrische, baseline-kontrollierte offene Studie zur Evaluierung des Einflusses einer “Single pill combination” auf die Blutdrucksenkung bei Patienten mit nicht-kontrolliertem Blutdruck unter freier Therapie |
|
|
| | 3 | 62 | Europe | Rasilez HCT 150mg/25mg, Rasilez HCT 300mg/25 mg, Exforge 5mg/160mg, Exforge 10mg/160 mg, Rasilez HCT 150mg/25mg, Rasilez HCT 300mg/25 mg, Exforge 5mg/160mg, Exforge 10mg/160 mg | Charité-Universitätsmedizin Berlin | Hypertension | | 04/12 | | |
2006-002621-23: A 54-week, open-label, multicenter study to assess the long-term safety and tolerability of the combination of aliskiren 300mg/ valsartan 320 mg in patients with essential hypertension. |
|
|
| | 3 | 100 | Europe | Aliskiren, Valsartan, Hydrochlorothiazide, SPP100, VAL489, Diovan 160 mg comprimidos recubiertos con película, Esidrex, Diovan 160 mg comprimidos recubiertos con película, Esidrex | Novartis Pharma Services Ag, Novartis Pharma Services AG, Novartis Farmaceutica S.A. | Hypertension | | 01/08 | | |
