drugset / Trial / NCT01368536
Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes
RandomizedParallel-groupTriple-blindTreatment
Summary
This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-02
- Completion
- 2012-02
Outcome
Outcome not reported
Stopped: “Based on results from an ALTITUDE study interim analysis, testing aliskiren concomitantly with an ACE inhibitor or ARB, in diabetics with renal impairment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aliskiren | Small molecule | 150 mg | — |
| Comparator | Amlodipine | Other / unclassified | 5 mg | — |
| Comparator | Amlodipine | Other / unclassified | 10 mg | — |
| Comparator | Chlorthalidone | Other / unclassified | 15 mg | — |
| Comparator | Chlorthalidone | Other / unclassified | 25 mg | — |
| Subject | Valsartan | Unknown | 160 mg | — |